Intermittent Fasting for NAFLD in Adults

NCT04899102 | Recruiting DMC

• 1 other identifier: 2020P002672
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

NAFLD is a growing threat to public health. Currently, there is a significant need for highly effective treatments for NAFLD. Non-obese NAFLD (BMI\<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. The purpose of this study is to identify non-pharmacologic, lifestyle-based methods of NAFLD treatment within non-obese adults.

Conditions

Fatty Liver; Liver Fat; Intermittent Fasting; Fatty Liver, Nonalcoholic; Non-Alcoholic Fatty Liver Disease

Keywords

Fatty Liver; Intermittent Fasting; Non-obese; Diet; Nutrition; Time-restricted; Liver Fat; Non-Alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (1)

• Liver Fat Content

  Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy (H-MRS)

  change from baseline to 6 weeks

Secondary Outcomes (4)

• ≥30% Relative Liver Fat Reduction Proportion

  change from baseline to 6 weeks

• Visceral Adipose Tissue Content

  change from baseline to 6 weeks

• Quality of Life Score

  change from baseline to 6 weeks

• Dietary Intake

  change from baseline to 6 weeks

Study Arms (1)

Time-Restricted, Intermittent Fasting Group

EXPERIMENTAL

Special type of diet for 6 weeks, called time-restricted, intermittent fasting.

Behavioral: Time-Restricted, Intermittent Fasting

Interventions

Time-Restricted, Intermittent Fasting BEHAVIORAL

A special type of diet for 6 weeks, called time-restricted, intermittent fasting.

Time-Restricted, Intermittent Fasting Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent
• Age 18 years or older at time of consent
• BMI 23-30kg/m\^2 at screening
• Evidence of NAFLD confirmed by historical procedure obtained no more than 6 months prior to the screening visit, defined as:
• Grade \>=1 steatosis on clinical liver biopsy; OR
• Fatty liver on validated imaging modality (non-contrast CT scan, MR Spectroscopy, MRI proton density fat fraction, ultrasound)
• Liver fat fraction ≥10% on H-MRS performed during the screening period
• Hepatitis C antibody and Hepatitis B surface antigen negative at screening

You may not qualify if:

• Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening \[heavy alcohol consumption is defined as: \> 20g daily for women or \> 30mg daily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)\].
• Evidence of other known forms of chronic liver disease including:
• Alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC).
• Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting.
• Use of any pharmacological treatments for NAFLD/NASH within the 6 months prior to the screening visit, except vitamin E. Patients on a stable dose of vitamin E can be enrolled in the study.
• Unstable body weight \[defined as: \>10% reduction in body weight in the 6 months prior to the screening visit\]
• Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam.
• Current or prior history of Child-Pugh score ≥7.
• History of liver transplant, or current placement on a liver transplant list.
• Known positivity for human immunodeficiency virus infection.
• Prior or planned bariatric surgery, patients on active pharmacological treatment for weight loss, or active involvement in a weight loss program.
• Chronic Kidney Disease (CKD) with eGFR \< 60.
• For women of child-bearing potential (WOCBP): positive urine hCG, trying to achieve pregnancy, or breastfeeding \[a negative urine pregnancy test is required at screening for women of child-bearing potential\].
• Other medical conditions or severe chronic illnesses that, in the opinion of the Investigator, may present a contraindication to study participation.
• Any other condition that, in the opinion of the Investigator, may hinder study compliance or completion of the study schedule of assessments.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Fatty Liver; Intermittent Fasting; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Kathleen Corey, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen E Corey, MD/MPH

CONTACT

6177265925; kathleen.corey@mgh.harvard.edu

Jenna Gustafson, MS

CONTACT

6177243836; JLGustafson@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Fatty Liver Clinic Assistant Professor, Harvard Medical School

Model Details: Every individual enrolled will follow a special type of diet for 6 weeks, called time-restricted, intermittent fasting.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)