Trial Outcomes & Findings for Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism (NCT NCT04283942)
NCT ID: NCT04283942
Last Updated: 2024-09-23
Results Overview
Change of liver fat content in %.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
From baseline to week 12
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
Intermittent Calorie Restriction (ICR)
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism
Baseline characteristics by cohort
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
47.9 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Duration of MASLD
|
9.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
8.6 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Height
|
165.4 cm
STANDARD_DEVIATION 8.3 • n=5 Participants
|
168.9 cm
STANDARD_DEVIATION 8.8 • n=7 Participants
|
167.2 cm
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Weight
|
79.4 kg
STANDARD_DEVIATION 11.4 • n=5 Participants
|
88.6 kg
STANDARD_DEVIATION 19.5 • n=7 Participants
|
84.0 kg
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Body mass index
|
29.0 kg/m2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
31.1 kg/m2
STANDARD_DEVIATION 5.3 • n=7 Participants
|
30.0 kg/m2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Waist circumference
|
97.6 cm
STANDARD_DEVIATION 7.5 • n=5 Participants
|
100.3 cm
STANDARD_DEVIATION 13 • n=7 Participants
|
98.9 cm
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Visceral adipose area
|
194.4 cm2
STANDARD_DEVIATION 56.4 • n=5 Participants
|
195.7 cm2
STANDARD_DEVIATION 56.2 • n=7 Participants
|
195.0 cm2
STANDARD_DEVIATION 55.8 • n=5 Participants
|
|
Subcutaneous adipose area
|
315.5 cm2
STANDARD_DEVIATION 82.4 • n=5 Participants
|
335.5 cm2
STANDARD_DEVIATION 125.2 • n=7 Participants
|
325.4 cm2
STANDARD_DEVIATION 105.2 • n=5 Participants
|
|
Lean mass
|
51.5 kg
STANDARD_DEVIATION 10.0 • n=5 Participants
|
57 kg
STANDARD_DEVIATION 12.8 • n=7 Participants
|
54.1 kg
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Fat mass
|
27.9 kg
STANDARD_DEVIATION 7.2 • n=5 Participants
|
31.8 kg
STANDARD_DEVIATION 10.1 • n=7 Participants
|
29.8 kg
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Systolic blood pressure
|
135.4 mmHg
STANDARD_DEVIATION 17.2 • n=5 Participants
|
134.3 mmHg
STANDARD_DEVIATION 16.6 • n=7 Participants
|
134.8 mmHg
STANDARD_DEVIATION 16.8 • n=5 Participants
|
|
Diastolic blood pressure
|
82.1 mmHg
STANDARD_DEVIATION 11.1 • n=5 Participants
|
81.4 mmHg
STANDARD_DEVIATION 10.2 • n=7 Participants
|
81.8 mmHg
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Fasting plasma glucose
|
115.6 mg/dL
STANDARD_DEVIATION 22.0 • n=5 Participants
|
111.8 mg/dL
STANDARD_DEVIATION 17.1 • n=7 Participants
|
113.8 mg/dL
STANDARD_DEVIATION 19.6 • n=5 Participants
|
|
2h postprandial plasma glucose
|
205.9 mg/dL
STANDARD_DEVIATION 74.2 • n=5 Participants
|
171.2 mg/dL
STANDARD_DEVIATION 79.6 • n=7 Participants
|
188.5 mg/dL
STANDARD_DEVIATION 78.1 • n=5 Participants
|
|
HbA1c
|
6.2 %
STANDARD_DEVIATION 0.8 • n=5 Participants
|
5.9 %
STANDARD_DEVIATION 0.6 • n=7 Participants
|
6.1 %
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Fasting insulin
|
19.0 μU/mL
STANDARD_DEVIATION 11.8 • n=5 Participants
|
23.5 μU/mL
STANDARD_DEVIATION 15.4 • n=7 Participants
|
21.3 μU/mL
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Homeostasis model assessment of insulin resistance (HOMA-IR) index
|
5.5 index
STANDARD_DEVIATION 4.0 • n=5 Participants
|
6.4 index
STANDARD_DEVIATION 4.2 • n=7 Participants
|
6.0 index
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Total cholesterol
|
182.6 mg/dL
STANDARD_DEVIATION 33.2 • n=5 Participants
|
189.6 mg/dL
STANDARD_DEVIATION 29.7 • n=7 Participants
|
186.1 mg/dL
STANDARD_DEVIATION 31.7 • n=5 Participants
|
|
Triglycerides
|
152.2 mg/dL
STANDARD_DEVIATION 68.1 • n=5 Participants
|
184.1 mg/dL
STANDARD_DEVIATION 146 • n=7 Participants
|
168.2 mg/dL
STANDARD_DEVIATION 114.2 • n=5 Participants
|
|
HDL cholesterol
|
44.8 mg/dL
STANDARD_DEVIATION 6.9 • n=5 Participants
|
45.9 mg/dL
STANDARD_DEVIATION 13.9 • n=7 Participants
|
45.3 mg/dL
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
LDL cholesterol
|
107.3 mg/dL
STANDARD_DEVIATION 30.1 • n=5 Participants
|
110.0 mg/dL
STANDARD_DEVIATION 26.6 • n=7 Participants
|
108.9 mg/dL
STANDARD_DEVIATION 28.2 • n=5 Participants
|
|
Free fatty acids
|
17.2 mg/dL
STANDARD_DEVIATION 5.9 • n=5 Participants
|
14.1 mg/dL
STANDARD_DEVIATION 4.8 • n=7 Participants
|
15.5 mg/dL
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Alanine aminotransferase
|
51.5 U/L
STANDARD_DEVIATION 38.6 • n=5 Participants
|
37.1 U/L
STANDARD_DEVIATION 22.4 • n=7 Participants
|
44.3 U/L
STANDARD_DEVIATION 32.1 • n=5 Participants
|
|
Aspartate aminotransferase
|
32.3 U/L
STANDARD_DEVIATION 18.3 • n=5 Participants
|
24.3 U/L
STANDARD_DEVIATION 10.2 • n=7 Participants
|
28.3 U/L
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
γ-Glutamyl transpeptidase
|
39.6 U/L
STANDARD_DEVIATION 24.6 • n=5 Participants
|
36.2 U/L
STANDARD_DEVIATION 20.3 • n=7 Participants
|
37.9 U/L
STANDARD_DEVIATION 22.4 • n=5 Participants
|
|
Liver fat content by 1H-MRS
|
37.7 %
STANDARD_DEVIATION 16.2 • n=5 Participants
|
38.5 %
STANDARD_DEVIATION 16.1 • n=7 Participants
|
38.1 %
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Whole liver
|
13.7 %
STANDARD_DEVIATION 7.3 • n=5 Participants
|
14.3 %
STANDARD_DEVIATION 7.9 • n=7 Participants
|
14.0 %
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Couinaud Segment 1
|
13.1 %
STANDARD_DEVIATION 7.2 • n=5 Participants
|
13.1 %
STANDARD_DEVIATION 7.3 • n=7 Participants
|
13.1 %
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Couinaud Segment 2
|
12.9 %
STANDARD_DEVIATION 6.8 • n=5 Participants
|
13.4 %
STANDARD_DEVIATION 7.7 • n=7 Participants
|
13.1 %
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Couinaud Segment 3
|
13.5 %
STANDARD_DEVIATION 7.3 • n=5 Participants
|
13.9 %
STANDARD_DEVIATION 7.7 • n=7 Participants
|
13.7 %
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Couinaud Segment 4
|
13.4 %
STANDARD_DEVIATION 7.2 • n=5 Participants
|
13.9 %
STANDARD_DEVIATION 7.6 • n=7 Participants
|
13.6 %
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Couinaud Segment 5
|
13.9 %
STANDARD_DEVIATION 7.6 • n=5 Participants
|
14.5 %
STANDARD_DEVIATION 8.3 • n=7 Participants
|
14.1 %
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Couinaud Segment 6
|
13.6 %
STANDARD_DEVIATION 7.6 • n=5 Participants
|
13.9 %
STANDARD_DEVIATION 8 • n=7 Participants
|
13.7 %
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Couinaud Segment 7
|
13.9 %
STANDARD_DEVIATION 7.3 • n=5 Participants
|
14.4 %
STANDARD_DEVIATION 7.8 • n=7 Participants
|
14.1 %
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
Couinaud Segment 8
|
14.0 %
STANDARD_DEVIATION 7.3 • n=5 Participants
|
14.9 %
STANDARD_DEVIATION 8.1 • n=7 Participants
|
14.4 %
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Controlled attenuation parameter
|
315.7 dB/m
STANDARD_DEVIATION 43.9 • n=5 Participants
|
320.2 dB/m
STANDARD_DEVIATION 42.9 • n=7 Participants
|
317.9 dB/m
STANDARD_DEVIATION 43.1 • n=5 Participants
|
|
Liver stiffness
|
6.2 kPa
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.8 kPa
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.0 kPa
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Comorbidities
Impaired glucose regulation
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Comorbidities
Type 2 diabetes
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Comorbidities
Hyperlipidaemia
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Comorbidities
Hypertension
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Concomitant drug use
Anti-lipidaemic
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Concomitant drug use
Anti-hypertensive
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 12Change of liver fat content in %.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Liver Fat Content in %
Liver fat content measured by 1H-MRS
|
-20.5 absolute fat content change in %
Interval -25.0 to -15.9
|
-15.5 absolute fat content change in %
Interval -20.3 to -10.8
|
|
Change of Liver Fat Content in %
Liver fat content measured by MRI-PDFF
|
-7.6 absolute fat content change in %
Interval -9.7 to -5.5
|
-7.3 absolute fat content change in %
Interval -10.3 to -4.3
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of weight in kilograms.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Weight
|
-5.3 kg
Interval -6.4 to -4.2
|
-3.8 kg
Interval -5.0 to -2.6
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of fasting blood glucose in mg/dL.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Blood Glucose: Fasting Blood Glucose
|
-12.6 mg/dL
Interval -18.9 to -6.3
|
-10.8 mg/dL
Interval -16.0 to -5.4
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of 2h postload blood glucose in mg/dL.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Blood Glucose: 2h Postload Blood Glucose
|
-50.6 mg/dL
Interval -67.9 to -33.3
|
-71.6 mg/dL
Interval -94.9 to -48.6
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of HbA1c in %.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of HbA1c
|
-0.5 HbA1c in %
Interval -0.7 to -0.3
|
-0.1 HbA1c in %
Interval -0.2 to -0.02
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of alanine aminotransferase in U/L.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Liver Enzymes: Alanine Aminotransferase
|
-24.8 U/L
Interval -35.4 to -14.2
|
-10.1 U/L
Interval -14.3 to -5.9
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of aspartate aminotransferase in U/L.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Liver Enzymes: Aspartate Aminotransferase
|
-11.5 U/L
Interval -17.0 to -5.9
|
-4.3 U/L
Interval -6.8 to -1.8
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of γ-glutamyl transpeptidase in U/L.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Liver Enzymes: γ-glutamyl Transpeptidase
|
-16.5 U/L
Interval -25.0 to -8.0
|
-6.3 U/L
Interval -12.3 to -0.3
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of total cholesterol in mg/dL.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Lipid Profile: Total Cholesterol
|
-3.9 mg/dL
Interval -13.9 to 6.2
|
-4.6 mg/dL
Interval -13.1 to 3.9
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of triglyceride in mg/dL.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Lipid Profile: Triglyceride
|
-24.8 mg/dL
Interval -46.0 to -3.5
|
-45.1 mg/dL
Interval -85.8 to -5.3
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of high-density lipoprotein-cholesterol in mg/dL.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Lipid Profile: High-density Lipoprotein-cholesterol
|
5.8 mg/dL
Interval 3.5 to 7.7
|
1.2 mg/dL
Interval -0.8 to 3.1
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of low-density lipoprotein-cholesterol in mg/dL.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Lipid Profile: Low-density Lipoprotein-cholesterol
|
-4.6 mg/dL
Interval -14.3 to 5.0
|
0.8 mg/dL
Interval -7.7 to 8.9
|
SECONDARY outcome
Timeframe: From baseline to week 12Change of free fatty acid in mg/dL.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Lipid Profile: Free Fatty Acid
|
-1.7 mg/dL
Interval -4.0 to 0.3
|
-1.4 mg/dL
Interval -3.1 to 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to week 12measured by bioimpedance analyzer, fat mass in kilograms.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Fat Mass
|
-4.5 kg
Interval -5.6 to -3.3
|
-2.6 kg
Interval -3.5 to -1.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to week 12measured by bioimpedance analyzer, skeletal muscle mass in kilograms.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Lean Mass
|
-0.8 kg
Interval -1.5 to -0.1
|
-1 kg
Interval -1.8 to -0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to week 12measured by MRI, including visceral adipose and subcutaneous adipose, all in square centimeter.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Abdominal Adipose Tissue Area
Visceral adipose area
|
-45.4 square centimeter
Interval -60.1 to -30.8
|
-38.7 square centimeter
Interval -51.6 to -25.9
|
|
Change of Abdominal Adipose Tissue Area
Subcutaneous adipose area
|
-43.9 square centimeter
Interval -63.2 to -24.6
|
-30.4 square centimeter
Interval -52.3 to -8.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to week 12Change of liver stiffness measure of liver transient elastography, in kPa.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Liver Stiffness Measure of Liver Transient Elastography
|
-0.8 kPa
Interval -1.3 to -0.3
|
-0.7 kPa
Interval -1.3 to -0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to week 12Change of HOMA-IR index from baseline to week 12. HOMA-IR index was calculated as fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l)/22.5. A HOMA-IR index higher than 75th quartile of non diabetes subjects is considered to be insulin resistance. However, due to differences in race, gender and research subjects, there is currently no recognized cut-off point. The cut-off values of HOMA-IR reported in previous studies varied greatly. A study on Caucasian non diabetes population showed that the cut-off value is 2.29. And a Chinese study proposed that the cut-off value of population over 40 years old in Shanghai was 4.31 for men and 4.51 for women.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index
|
-2 index
Interval -3.2 to -0.8
|
-1.6 index
Interval -2.7 to -0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to week 12Change of fasting insulin in μU/mL.
Outcome measures
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 Participants
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 Participants
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
Change of Fasting Insulin
|
-5.3 μU/mL
Interval -8.7 to -1.8
|
-3.7 μU/mL
Interval -7.5 to 0.2
|
Adverse Events
Intermittent Calorie Restriction (ICR)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Control (Continuous Calorie Restriction, CCR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intermittent Calorie Restriction (ICR)
n=30 participants at risk
Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
Control (Continuous Calorie Restriction, CCR)
n=30 participants at risk
Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
|
|---|---|---|
|
General disorders
Fatigue/Weakness
|
16.7%
5/30 • Number of events 5 • From 1 to 12 weeks.
No participant was at risk for Serious Adverse Events. No participant was at risk for All-Cause Mortality.
|
0.00%
0/30 • From 1 to 12 weeks.
No participant was at risk for Serious Adverse Events. No participant was at risk for All-Cause Mortality.
|
|
General disorders
Dysphoria
|
10.0%
3/30 • Number of events 3 • From 1 to 12 weeks.
No participant was at risk for Serious Adverse Events. No participant was at risk for All-Cause Mortality.
|
0.00%
0/30 • From 1 to 12 weeks.
No participant was at risk for Serious Adverse Events. No participant was at risk for All-Cause Mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place