Alternate Day Fasting, Exercise, and NAFLD

NCT04004403 | Completed Results

• 2 other identifiers: 2019-0300R01DK119783
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Hepatic Steatosis

  Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF)

  Change from week 1 to week 12

Secondary Outcomes (7)

• Change in Body Weight

  Change from week 1 to week 12

• Change in Alanine Aminotransferase (ALT)

  Change from week 1 to week 12

• Change in Aspartate Aminotransferase (AST)

  Change from week 1 to week 12

• Change in Fasting Glucose

  Change from week 1 to week 12

• Change in Fasting Insulin

  Change from week 1 to week 12

Study Arms (4)

Alternate day fasting

EXPERIMENTAL

These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".

Other: Alternate day fasting

Exercise

EXPERIMENTAL

These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.

Other: Exercise

Combination alternate day fasting plus exercise

EXPERIMENTAL

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.

Other: Alternate day fasting; Other: Exercise

Control

NO INTERVENTION

Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.

Interventions

Alternate day fasting OTHER

The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".

Alternate day fasting; Combination alternate day fasting plus exercise

Exercise OTHER

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; Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (\<20 min, 2x/week of light activity at 3-4 metabolic equivalents (METs) for 3 mo prior to study)

You may not qualify if:

• Have chronic liver disease other than NAFLD (hepatitis B or C, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency)
• Consume excessive amounts of alcohol women: 70 g of ethanol (5 alcoholic drinks per week) and men 140 g of ethanol (10 drinks per week) in the past 6 months)
• Have a history of known cardiovascular, pulmonary or renal disease
• Diagnosed T1DM or T2DM
• Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Krista Varady
• Organization: University of Illinois Chicago

varady@uic.edu

3129967897

Study Officials

• Krista Varady, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: September 1, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 25, 2025
• Results First Posted: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)