Trial Outcomes & Findings for Alternate Day Fasting, Exercise, and NAFLD (NCT NCT04004403)
NCT ID: NCT04004403
Last Updated: 2025-09-25
Results Overview
Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Change from week 1 to week 12
Results posted on
2025-09-25
Participant Flow
Participant milestones
| Measure |
Alternate Day Fasting
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
15
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alternate Day Fasting, Exercise, and NAFLD
Baseline characteristics by cohort
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
Total
n=80 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 16 • n=5 Participants
|
44 years
STANDARD_DEVIATION 13 • n=7 Participants
|
44 years
STANDARD_DEVIATION 13 • n=5 Participants
|
44 years
STANDARD_DEVIATION 12 • n=4 Participants
|
44 years
STANDARD_DEVIATION 13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change from week 1 to week 12Population: Adults with obesity and NAFLD
Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF)
Outcome measures
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Change in Hepatic Steatosis
|
-2.25 liver fat percentage
Interval -4.46 to -0.04
|
-1.3 liver fat percentage
Interval -3.8 to 1.2
|
-5.48 liver fat percentage
Interval -7.77 to -3.18
|
-0.17 liver fat percentage
Interval -2.17 to 1.83
|
SECONDARY outcome
Timeframe: Change from week 1 to week 12Population: Adults with obesity and NAFLD
Measured by digital scale
Outcome measures
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Change in Body Weight
|
-4.45 kg
Interval -4.93 to -3.97
|
-1.79 kg
Interval -2.33 to -1.26
|
-4.18 kg
Interval -4.65 to -3.71
|
-0.52 kg
Interval to -0.05
|
SECONDARY outcome
Timeframe: Change from week 1 to week 12Population: Adults with obesity and NAFLD
Measured by a commercial lab (Medstar, Inc)
Outcome measures
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Change in Alanine Aminotransferase (ALT)
|
-11.24 U/L
Interval -26.12 to 3.64
|
-0.70 U/L
Interval -5.03 to 3.64
|
-5.97 U/L
Interval -10.66 to -1.28
|
0.65 U/L
Interval -1.9 to 3.2
|
SECONDARY outcome
Timeframe: Change from week 1 to week 12Population: Adults with obesity and NAFLD
Measured by a commercial lab (Medstar, Inc)
Outcome measures
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Change in Aspartate Aminotransferase (AST)
|
-5.39 U/L
Interval -9.8 to -0.98
|
.34 U/L
Interval -4.71 to 5.39
|
-1.59 U/L
Interval -5.98 to 2.79
|
-0.33 U/L
Interval -4.51 to 3.85
|
SECONDARY outcome
Timeframe: Change from week 1 to week 12Population: Adults with obesity and NAFLD
Measured by a commercial lab (Medstar, Inc)
Outcome measures
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Change in Fasting Glucose
|
-5.14 mg/dl
Interval -11.64 to 1.35
|
-2.12 mg/dl
Interval -9.75 to 5.5
|
-5.28 mg/dl
Interval -11.76 to 1.21
|
.62 mg/dl
Interval -5.67 to 6.9
|
SECONDARY outcome
Timeframe: Change from week 1 to week 12Population: Adults with obesity and NAFLD
Measured by a commercial lab (Medstar, Inc)
Outcome measures
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Change in Fasting Insulin
|
-7.41 uIU/mL
Interval -13.58 to -1.24
|
-3.93 uIU/mL
Interval -8.87 to 1.01
|
-9.59 uIU/mL
Interval -15.16 to -4.02
|
1.22 uIU/mL
Interval -2.48 to 4.92
|
SECONDARY outcome
Timeframe: Change from week 1 to week 12Population: Adults with obesity and NAFLD
Measured by Homeostatic model assessment of insulin resistance (HOMA-IR). The HOMA-IR value was calculated using the formula: \[HOMA-IR = glucose (mg/dL) × insulin (mU/L)/405\]. Interpretation of HOMA-IR Scores: \< 1.0: Normal insulin sensitivity; 1.0-1.9: Mild insulin resistance; \> 2.0: Moderate to severe insulin resistance.
Outcome measures
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Change in Insulin Resistance
|
-1.8 index
Interval -3.07 to -0.54
|
-1.25 index
Interval -2.76 to 0.27
|
-2.55 index
Interval -4.03 to -1.08
|
0.49 index
Interval -0.83 to 1.8
|
SECONDARY outcome
Timeframe: Change from week 1 to week 12Population: Adults with obesity and NAFLD
Measured by a commercial lab (Medstar, Inc)
Outcome measures
| Measure |
Alternate Day Fasting
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
|
Exercise
n=20 Participants
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Combination Alternate Day Fasting Plus Exercise
n=20 Participants
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
|
Control
n=20 Participants
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
|
|---|---|---|---|---|
|
Change in HbA1c
|
-.12 percentage of glycosylated hemoglobin
Interval -0.24 to 0.01
|
.02 percentage of glycosylated hemoglobin
Interval -0.13 to 0.16
|
-0.08 percentage of glycosylated hemoglobin
Interval -0.2 to 0.05
|
.04 percentage of glycosylated hemoglobin
Interval -0.08 to 0.16
|
Adverse Events
Alternate Day Fasting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination Alternate Day Fasting Plus Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place