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Intermittent Fasting for NAFLD in Adults

Primary Purpose

Fatty Liver, Intermittent Fasting, Fatty Liver, Nonalcoholic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time-Restricted, Intermittent Fasting
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring Fatty Liver, Intermittent Fasting, Non-obese, Diet, Nutrition, Time-restricted, Liver Fat, Non-Alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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

Exclusion Criteria:

  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:

    • 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).

  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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Time-Restricted, Intermittent Fasting Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

≥30% Relative Liver Fat Reduction Proportion
Proportion of subjects with a ≥30% relative reduction in hepatic fat
Visceral Adipose Tissue Content
Visceral Adipose Tissue Content as measured by magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS)
Quality of Life Score
Quality of Life Score as measured by Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD)
Dietary Intake
Dietary Intake as measured by caloric intake and nutrient contents, assessed by ASA24

Full Information

First Posted
May 19, 2021
Last Updated
March 9, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04899102
Brief Title
Intermittent Fasting for NAFLD in Adults
Official Title
Pilot Study of Time-Restricted, Intermittent Fasting for Non-Alcoholic Fatty Liver Disease in Non-Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Nonalcoholic fatty liver disease (NAFLD), which encompasses a spectrum from simple steatosis and steatohepatitis (NASH) to fibrosis and cirrhosis, is the leading cause of liver disease in the United States. There are currently no FDA-approved pharmacologic therapies for NAFLD and NASH, and standard low-calorie diets are often minimally effective, difficult to adhere to and to maintain. Thus, continued investigation of strategies to treat NAFLD and NASH is greatly needed. Non-obese NAFLD (BMI<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". It is estimated that 10-20% of American and Europeans without obesity have this condition. There is a pressing need for the study of lifestyle interventions independent of weight loss to treat this important subset of NAFLD patients. This protocol aims to investigate the utility of time restricted, intermittent fasting (TRF) as a potential method. Adults with non-obese NAFLD are at risk of progression to end-stage liver disease and development of cardiometabolic disease. Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. IF is characterized by periods of dietary restriction leading to metabolic production and use of ketones from adipocytes rather than hepatically-derived glucose. The goal of this study is to learn if time-restricted, intermittent fasting can help reduce the amount of fat in the liver in adults with non-alcoholic fatty liver disease (NAFLD). Ideally, this study will yield more information about time-restricted, intermittent fasting as a potential lifestyle-based treatment for adults with NAFLD and a body mass index (BMI) between 23-30 kg/m^2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Intermittent Fasting, Fatty Liver, Nonalcoholic, Non-Alcoholic Fatty Liver Disease, Liver Fat
Keywords
Fatty Liver, Intermittent Fasting, Non-obese, Diet, Nutrition, Time-restricted, Liver Fat, Non-Alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Every individual enrolled will follow a special type of diet for 6 weeks, called time-restricted, intermittent fasting.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-Restricted, Intermittent Fasting Group
Arm Type
Experimental
Arm Description
Special type of diet for 6 weeks, called time-restricted, intermittent fasting.
Intervention Type
Behavioral
Intervention Name(s)
Time-Restricted, Intermittent Fasting
Intervention Description
A special type of diet for 6 weeks, called time-restricted, intermittent fasting.
Primary Outcome Measure Information:
Title
Liver Fat Content
Description
Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy (H-MRS)
Time Frame
change from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
≥30% Relative Liver Fat Reduction Proportion
Description
Proportion of subjects with a ≥30% relative reduction in hepatic fat
Time Frame
change from baseline to 6 weeks
Title
Visceral Adipose Tissue Content
Description
Visceral Adipose Tissue Content as measured by magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS)
Time Frame
change from baseline to 6 weeks
Title
Quality of Life Score
Description
Quality of Life Score as measured by Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD)
Time Frame
change from baseline to 6 weeks
Title
Dietary Intake
Description
Dietary Intake as measured by caloric intake and nutrient contents, assessed by ASA24
Time Frame
change from baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen E Corey, MD/MPH
Phone
6177265925
Email
kathleen.corey@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hayley Schultz, BA
Phone
6176437480
Email
HSCHULTZ@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen E Corey, MD/MPH
Phone
617-726-5925
Email
kathleen.corey@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hayley Schultz, BA
Phone
6176437480
Email
HSCHULTZ@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Final Research Data, with all patient identifiers removed, will be available to other researchers through request to the PI. Because information contained in the final research data will include multiple demographic and biological variables that could potentially be used in concert to identify participants, it will be shared only under a Data Sharing Agreement that includes (1) a commitment to using the data only for research purposes and not to identify any individual participant and (2) a commitment to destroying or returning the data after analyses are completed.

Learn more about this trial

Intermittent Fasting for NAFLD in Adults

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