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Fasting for Non-alcoholic Fatty Liver Disease

N/A
Waitlist Available
Led By Jody Dushay, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after the 72-hour fast or hypocaloric diet in participants with nafld
Awards & highlights

Study Summary

This trial is examining the effect of fasting, dieting, and sugar consumption on the levels of the protein FGF-21. The study will enroll obese adults with non-alcoholic fatty liver disease, as well as lean volunteers and individuals with metabolic syndrome.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease
  • Fasting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after dietary intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after dietary intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fibroblast Growth Factor 21 levels in serum and fat
Secondary outcome measures
Hepatic fat content
Polymerase 1 and Transcript Release Factor levels in fat
Urine and serum ketosis
+2 more

Side effects data

From 2015 Phase 4 trial • 15 Patients • NCT01380366
7%
Hospitalization for Escherichia coli Infection
7%
Hospitalization for Gram-positive Cocci
7%
Hospitalization for positive line infection
7%
Pancreatitis
7%
Hospitalization for abdominal pain (pre-treatment)
7%
Hospitalization for Flu like Symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients Consented to be Given rHGH

Trial Design

4Treatment groups
Experimental Treatment
Group I: Oral carbohydrate challengeExperimental Treatment1 Intervention
Participants will fast for 16 hours overnight then ingest drinks containing fructose, glucose or a mixture of fructose and glucose. Blood will be drawn postprandially at specified timepoints for up to 5 hours
Group II: Hypocaloric diet (NAFLD)Experimental Treatment1 Intervention
Participants will follow a low-calorie diet until they lose 3-5% of their body weight. Participants will have weekly outpatient visits at Beth Israel Deaconess Medical Center in Boston, MA for weight measurements. Participants will have blood drawn before and after the diet. Participants will also have an MRI before and after the diet.
Group III: Fasting (NAFLD)Experimental Treatment1 Intervention
Participants with liver-biopsy diagnosed non-alcoholic fatty liver disease (NAFLD) will fast for 72 hours during an inpatient stay at the Beth Israel Deaconess Medical Center in Boston, MA. Blood samples will be collected daily, and participants will have an MRI before and after the fast.
Group IV: Fasting (Healthy).Experimental Treatment1 Intervention
Participants will fast for 72 hours during an inpatient stay at the Beth Israel Deaconess Medical Center in Boston, MA. Blood samples will be collected daily and two fat samples will be obtained by a trained surgeon. (We are no longer recruiting for Study Arm A).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diet
2000
Completed Phase 4
~15300
oral carbohydrate challenge
2016
N/A
~90
Fasting
2019
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,296 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
78 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Jody Dushay, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to take part in this research?

"This medical trail necessitates that its participants must possess fatty liver and are aged from 18 to 60. The trial is accepting around 40 applicants in total."

Answered by AI

Does this clinical experiment welcome senior citizens as participants?

"Individuals between the ages of 18 to 60 are eligible for this trial, while 35 other studies cater to minors and 327 study opportunities exist for seniors."

Answered by AI

Is there any availability for participants in this trial?

"According to clinicaltrials.gov, this research project is no longer recruiting participants; although the initial post date was July 1st 2009 and the most recent update occurred on July 18th 2022, it has since been superseded by 382 other trials actively seeking patients."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Massachusetts
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Regulation of FGF21 by Nutritional Challenges
Jody Dushay 2009. "Regulation of FGF21 by Nutritional Challenges". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00968747.
~3 spots leftby Apr 2025
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