Trial Outcomes & Findings for 2-5 Intermittent Caloric Restriction in HIV (NCT NCT03489109)
NCT ID: NCT03489109
Last Updated: 2022-10-21
Results Overview
The effect of intermittent fasting was measured by change in weight between baseline and at week 12
TERMINATED
NA
35 participants
Assessed before 12-week intervention (baseline) and at week 12
2022-10-21
Participant Flow
Of the 35 subjects who were consented to protocol, four subjects withdrew prior to start of study, one subject was screen failure and 30 subjects started the study.
Participant milestones
| Measure |
Intermittent Fasting Diet
HIV positive subjects with body mass index =30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
HIV positive subjects with body mass index =30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Intermittent Fasting Diet
HIV positive subjects with body mass index =30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
HIV positive subjects with body mass index =30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
2-5 Intermittent Caloric Restriction in HIV
Baseline characteristics by cohort
| Measure |
Intermittent Fasting Diet
n=14 Participants
HIV positive subjects with body mass index ≥30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=16 Participants
HIV positive subjects with body mass index ≥30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Weight
|
112.1 kilograms
STANDARD_DEVIATION 18.4 • n=5 Participants
|
109.6 kilograms
STANDARD_DEVIATION 14.9 • n=7 Participants
|
110.8 kilograms
STANDARD_DEVIATION 16.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed before 12-week intervention (baseline) and at week 12Population: Analysis only includes subjects who completed through Week 12
The effect of intermittent fasting was measured by change in weight between baseline and at week 12
Outcome measures
| Measure |
Intermittent Fasting Diet
n=14 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=15 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Change in Weight
|
-1.5 kilograms
Standard Deviation 4.9
|
-1.8 kilograms
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Assessed before 12-week intervention (baseline) and at week 12Population: Analysis only includes subjects who completed study through Week 12
The effect of intermittent fasting on insulin sensitivity was measured by change in homeostatic model assessment of insulin resistance (HOMA-IR) between baseline and week 12. Homeostasis model assessment of insulin resistance (HOMA-IR) is a method to measure insulin sensitivity. Optimal insulin sensitivity is a HOMA-IR ratio less than 1. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance.
Outcome measures
| Measure |
Intermittent Fasting Diet
n=14 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=12 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Change in Insulin Sensitivity
|
-0.9 unitless
Standard Deviation 1.7
|
-1.5 unitless
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Assessed before 12-week intervention (baseline) and at week 12Population: Analysis only includes subjects who completed study through week 12. Unable to obtain a Fibroscan on 10 participants because of body habitus.
The effect of Intermittent fasting on body composition was evaluated using Controlled Attenuation Parameter (CAP) score from Fibroscan. Measurement of controlled attenuation parameter (CAP) is a non-invasive quantitative and qualitative assessment of liver steatosis. CAP measures ultrasonic attenuation (in dB/m) at a frequency of 3.5 MHz (on a go-and-return path). Values range from 100 to 400 dB/m. Higher levels indicate increased hepatic fat.
Outcome measures
| Measure |
Intermittent Fasting Diet
n=12 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=7 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Change in Controlled Attenuation Parameter (CAP) Score
|
-3.8 dB/m
Standard Deviation 28.3
|
-6.6 dB/m
Standard Deviation 74.6
|
SECONDARY outcome
Timeframe: Assessed before 12-week intervention (baseline) and at week 12Population: Analysis only includes subjects who completed study through week 12. Ten participants were unable to complete this exam
The effect of intermittent fasting was evaluated by change in visceral adiposity using total body dual energy x-ray absorptiometry (DEXA) between baseline and at week 12.
Outcome measures
| Measure |
Intermittent Fasting Diet
n=9 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=10 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Change in Visceral Adipose Tissue
|
-224 mg
Standard Deviation 206
|
-149 mg
Standard Deviation 541
|
SECONDARY outcome
Timeframe: Assessed before 12-week intervention (baseline) and at week 12Population: Analysis only includes subjects who completed study through week 12
The effect of Intermittent fasting was measured by change in lipid profile levels between baseline and week 12. Lipid profile levels assessed include serum triglyceride, HDL cholesterol, LDL cholesterol, and total cholesterol levels.
Outcome measures
| Measure |
Intermittent Fasting Diet
n=14 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=14 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Change in Lipid Panel Levels
Triglyceride
|
-4.8 mg/dL
Standard Deviation 23.5
|
0 mg/dL
Standard Deviation 22.9
|
|
Change in Lipid Panel Levels
HDL Cholesterol
|
-1.3 mg/dL
Standard Deviation 3.4
|
-2.7 mg/dL
Standard Deviation 5.7
|
|
Change in Lipid Panel Levels
LDL Cholesterol
|
1.6 mg/dL
Standard Deviation 17.0
|
1.6 mg/dL
Standard Deviation 10.9
|
|
Change in Lipid Panel Levels
Total Cholesterol
|
-0.6 mg/dL
Standard Deviation 17.4
|
-1 mg/dL
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Assessed before 12-week intervention (baseline) and at week 12Population: Analysis only includes subjects who completed study through week 12
The effect of Intermittent fasting on biomarker of inflammation was measured by C-reactive protein (CRP) levels between baseline and week 12
Outcome measures
| Measure |
Intermittent Fasting Diet
n=14 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=14 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Change in C-reactive Protein (CRP) Levels
|
1.7 mg/L
Standard Deviation 4.8
|
0.3 mg/L
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Assessed before 12-week intervention (baseline) and at week 12Population: Analysis only included subjects who completed study through week 12 and completed the questionnaire
The effect of Intermittent fasting on mood was evaluated by change in the Beck Depression Inventory (BDI) score between baseline and week 12. The Beck Depression Inventory (BDI) is a 21-item measure of depression with each question on a 4-point scale ranging from 0=minimal to 3 = more severe (full list score values = 0,1,2,3). Total scores are a sum of individual items. Minimal depression = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63. The maximum score is 63 and the minimum possible score is zero.
Outcome measures
| Measure |
Intermittent Fasting Diet
n=5 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=6 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Change in Beck Depression Inventory (BDI) Score
|
3.5 Units on a scale
Standard Deviation 6.8
|
8.6 Units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Compliance reported at Week 12Population: Analysis only included subjects who completed study through week 12. 11 subjects did not report their compliance rate.
Compliance with assigned diet was assessed by participant self-reported rating. Participants used a self rating score of 0-100% with 0% = noncompliant and 100% = completely compliant with assigned diet. Compliance rate per participant was calculated using average of all daily reported scores. The overall compliance rate was averaged over all participants to get the mean compliance.
Outcome measures
| Measure |
Intermittent Fasting Diet
n=7 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=11 Participants
Persons living with HIV and with body mass index \>/= 30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Self-reported Compliance Rate With Assigned Diet
|
80 Percentage of Compliance
Standard Deviation 16
|
67 Percentage of Compliance
Standard Deviation 22
|
Adverse Events
Intermittent Fasting Diet
Standard of Care Diet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intermittent Fasting Diet
n=14 participants at risk
HIV positive subjects with body mass index =30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
|
Standard of Care Diet
n=16 participants at risk
HIV positive subjects with body mass index =30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Localised oedema
|
7.1%
1/14 • 24 weeks
|
0.00%
0/16 • 24 weeks
|
|
Endocrine disorders
Diabetes mellitus
|
14.3%
2/14 • 24 weeks
|
0.00%
0/16 • 24 weeks
|
|
Endocrine disorders
Impaired fasting glucose
|
7.1%
1/14 • 24 weeks
|
12.5%
2/16 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
General disorders
Malaise
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
General disorders
Oedema
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • 24 weeks
|
0.00%
0/16 • 24 weeks
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Investigations
Blood bicarbonate decreased
|
14.3%
2/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Investigations
Blood cholesterol increased
|
7.1%
1/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14 • 24 weeks
|
18.8%
3/16 • 24 weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Investigations
Low density lipoprotein increased
|
7.1%
1/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • 24 weeks
|
0.00%
0/16 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
7.1%
1/14 • 24 weeks
|
0.00%
0/16 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/14 • 24 weeks
|
6.2%
1/16 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place