N/A
N=80
Alternate Day Fasting, Exercise, and NAFLD
Non-Alcoholic Fatty Liver Disease · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04004403 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Change in Hepatic Steatosis — -2.25; -1.3; -5.48; -0.17 liver fat percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alternate day fasting (Other); Exercise (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hepatic Steatosis |
-2.25; -1.3; -5.48; -0.17 | — |
| SECONDARY Change in Body Weight |
-4.45; -1.79; -4.18; -0.52 | — |
| SECONDARY Change in Alanine Aminotransferase (ALT) |
-11.24; -0.70; -5.97; 0.65 | — |
| SECONDARY Change in Aspartate Aminotransferase (AST) |
-5.39; .34; -1.59; -0.33 | — |
| SECONDARY Change in Fasting Glucose |
-5.14; -2.12; -5.28; .62 | — |
| SECONDARY Change in Fasting Insulin |
-7.41; -3.93; -9.59; 1.22 | — |
| SECONDARY Change in Insulin Resistance |
-1.8; -1.25; -2.55; 0.49 | — |
| SECONDARY Change in HbA1c |
-.12; .02; -0.08; .04 | — |
Summary
Approximately 65% of obese individuals have non-alcoholic fatty liver disease (NAFLD), and this condition is strongly related to the development of insulin resistance and diabetes. Innovative lifestyle strategies to treat NAFLD are critically needed. The proposed research will demonstrate that alternate day fasting (ADF) combined with exercise is an effective non-pharmacological therapy to treat NAFLD.
Eligibility Criteria
INCLUSION CRITERIA
- Age between 18 to 65 years old
- BMI between 30.0 and 59.9 kg/m2
- NAFLD (hepatic steatosis ≥ 5% confirmed by MRI-PDFF)
- Sedentary ( 4 kg)
- Are claustrophobic or have implanted metallic/electrical devices (e.g. cardiac pacemaker, neuro-stimulator)
- Are taking drugs that induce steatosis (e.g. corticosteroids, estrogens, methotrexate, Ca channel blockers)
- Are taking drugs that benefit NAFLD (e.g. betaine, pioglitazone, rosiglitazone, metformin, or gemifibrozil)
- Are taking drugs that influence study outcomes (weight loss medications)
- Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
- Are pregnant, or trying to become pregnant
- Are smokers
Data sourced from ClinicalTrials.gov (NCT04004403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.