RECRUITING

Intermittent Fasting for NAFLD in Adults

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study of Time-Restricted, Intermittent Fasting for Non-Alcoholic Fatty Liver Disease in Non-Obese Adults

Quick Facts

Study Start:2022-02-01

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04899102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Willing and able to provide informed consent 2. Age 18 years or older at time of consent 3. BMI 23-30kg/m\^2 at screening 4. 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) 5. Liver fat fraction ≥10% on H-MRS performed during the screening period 6. Hepatitis C antibody and Hepatitis B surface antigen negative at screening	1. Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening \[heavy alcohol consumption is defined as: \> 20g daily for women or \> 30mg daily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)\]. 2. Evidence of other known forms of chronic liver disease including: 3. Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting. 4. 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. 5. Unstable body weight \[defined as: \>10% reduction in body weight in the 6 months prior to the screening visit\] 6. Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam. 7. Current or prior history of Child-Pugh score ≥7. 8. History of liver transplant, or current placement on a liver transplant list. 9. Known positivity for human immunodeficiency virus infection. 10. Prior or planned bariatric surgery, patients on active pharmacological treatment for weight loss, or active involvement in a weight loss program. 11. Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip. 12. Chronic Kidney Disease (CKD) with eGFR \< 60. 13. For women of child-bearing potential (WOCBP): positive urine hCG, trying to achieve pregnancy, or breastfeeding \[a negative urine pregnancy test is required at screening for women of child-bearing potential\]. 14. Other medical conditions or severe chronic illnesses that, in the opinion of the Investigator, may present a contraindication to study participation. 15. Any other condition that, in the opinion of the Investigator, may hinder study compliance or completion of the study schedule of assessments.

Inclusion Criteria

Exclusion Criteria

1. Willing and able to provide informed consent
2. Age 18 years or older at time of consent
3. BMI 23-30kg/m\^2 at screening
4. 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)
5. Liver fat fraction ≥10% on H-MRS performed during the screening period
6. Hepatitis C antibody and Hepatitis B surface antigen negative at screening

1. Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening \[heavy alcohol consumption is defined as: \> 20g daily for women or \> 30mg daily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)\].
2. Evidence of other known forms of chronic liver disease including:
3. Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting.
4. 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.
5. Unstable body weight \[defined as: \>10% reduction in body weight in the 6 months prior to the screening visit\]
6. Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam.
7. Current or prior history of Child-Pugh score ≥7.
8. History of liver transplant, or current placement on a liver transplant list.
9. Known positivity for human immunodeficiency virus infection.
10. Prior or planned bariatric surgery, patients on active pharmacological treatment for weight loss, or active involvement in a weight loss program.
11. Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip.
12. Chronic Kidney Disease (CKD) with eGFR \< 60.
13. For women of child-bearing potential (WOCBP): positive urine hCG, trying to achieve pregnancy, or breastfeeding \[a negative urine pregnancy test is required at screening for women of child-bearing potential\].
14. Other medical conditions or severe chronic illnesses that, in the opinion of the Investigator, may present a contraindication to study participation.
15. Any other condition that, in the opinion of the Investigator, may hinder study compliance or completion of the study schedule of assessments.

Contacts and Locations

Study Contact

Kathleen E Corey, MD/MPH

CONTACT

6177265925

kathleen.corey@mgh.harvard.edu

Hayley Schultz, BA

CONTACT

6176437480

HSCHULTZ@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2022-02-01

Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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