Intermittent Fasting for NAFLD in Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide informed consent

Age 18 years or older at time of consent

BMI 23-30kg/m² at screening

Grade >=1 steatosis on clinical liver biopsy; OR

Disqualifiers

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)].

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]

Trial design

Design model

Single group

Treatments tested in this trial

  • Time-Restricted, Intermittent Fasting

    Behavioral

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Time-Restricted, Intermittent Fasting GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Liver Fat Content

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

Time frame
change from baseline to 6 weeks

Secondary outcomes

1

≥30% Relative Liver Fat Reduction Proportion

Proportion of subjects with a ≥30% relative reduction in hepatic fat

Time frame
change from baseline to 6 weeks
2

Visceral Adipose Tissue Content

Visceral Adipose Tissue Content as measured by magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS)

Time frame
change from baseline to 6 weeks
3

Quality of Life Score

Quality of Life Score as measured by Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD)

Time frame
change from baseline to 6 weeks
4

Dietary Intake

Dietary Intake as measured by caloric intake and nutrient contents, assessed by ASA24

Time frame
change from baseline to 6 weeks

Other outcomes

Sponsors and contacts

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