Regulation of FGF21 by Nutritional Challenges

Summary

The purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue.

This study will have several aims.

One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21 (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken. Two fat samples will be taken prior to and at the end of the fast. A subset of participants will also have two MRIs, one prior to and one at the end of the fast. We will study healthy adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING

Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for weight measurements. Blood will be drawn before and after the weight loss. Participants will also have an MRI before and after the weight loss.

THIS ARM IS CURRENTLY NOT RECRUITING

Another aim of the study is to examine the effect of acute ingestion of glucose, fructose, and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.

THIS ARM IS CURRENTLY RECRUITING

Conditions

• Fasting
• Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions

BEHAVIORAL

Fasting

Participants will fast for 72 hours and may consume only water and vitamins.

BEHAVIORAL

Fasting

Participants will fast for 72 hours and may consume only water and vitamins.

BEHAVIORAL

Diet

Participants will follow a low-calorie diet until they lose 3-5% of their body weight.

DIETARY_SUPPLEMENT

oral carbohydrate challenge

Participants will fast for 16 hours and then drink a beverage containing glucose, fructose or a mixture of both

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• Jody Dushay, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2023-07-31

Completion

2023-07-31

Countries

• United States

Study Locations