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NCT00968747 · ClinicalTrials.gov registry record · NA

Regulation of FGF21 by Nutritional Challenges

A NA study of Fasting and Non-Alcoholic Fatty Liver Disease (NAFLD), sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT00968747 is a NA study of Fasting and Non-Alcoholic Fatty Liver Disease (NAFLD) that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 40 participants, below the 205-participant average among 8 other Fasting trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00968747, a NA study of Fasting and Non-Alcoholic Fatty Liver Disease (NAFLD), has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

Study 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 Studied

Fasting Non-Alcoholic Fatty Liver Disease (NAFLD)

Interventions

  • BEHAVIORAL Diet
  • BEHAVIORAL Fasting
  • DIETARY_SUPPLEMENT oral carbohydrate challenge

Study Locations (1)

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2009-07
Est. Completion 2023-07-31
Phase NA

Sponsor

Beth Israel Deaconess Medical Center

488 total trials

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What the Registry Record Tells You About NCT00968747

The ClinicalTrials.gov registry entry for NCT00968747 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 8 other Fasting trials with a reported enrollment target (80% lower). The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Fasting appearing as the primary indexed condition, and to 3 interventions - of which Diet is the first listed.

NCT00968747 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00968747 about?

NCT00968747 is a clinical study titled "Regulation of FGF21 by Nutritional Challenges". 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 growt...

What is the current status of trial NCT00968747?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2009-07. Estimated completion is 2023-07-31.

What conditions does trial NCT00968747 study?

This clinical trial studies the following conditions: Fasting, Non-Alcoholic Fatty Liver Disease (NAFLD).

What interventions are being tested in trial NCT00968747?

The interventions under investigation include: Diet (BEHAVIORAL), Fasting (BEHAVIORAL), oral carbohydrate challenge (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00968747?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00968747 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.