An interventional study of Fasting and Fasting in Fasting and Non-alcoholic Fatty Liver Disease (NAFLD), sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Other
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
Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to 5 different sweet beverages, separated by 2 weeks.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
72-hour fast in healthy volunteers (Study Arm A):
Inclusion Criteria:
Exclusion Criteria:
Use of plavix, coumadin, or heparin
72-hour fast or hypocaloric diet in subjects with non-alcoholic fatty liver disease (NAFLD) (Study Arms B \& C):
Inclusion Criteria:
Exclusion Criteria:
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).
Behavioral: Fasting
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.
Behavioral: Fasting
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.
Behavioral: Diet
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
Dietary Supplement: oral carbohydrate challenge
Participants will fast for 72 hours and may consume only water and vitamins.
Participants will fast for 72 hours and may consume only water and vitamins.
Participants will follow a low-calorie diet until they lose 3-5% of their body weight.
Participants will fast for 16 hours and then drink a beverage containing glucose, fructose or a mixture of both
Fibroblast Growth Factor 21 levels in serum and fat
Change in FGF21 levels following nutritional intervention.
Time frame: before and after dietary intervention
Polymerase 1 and Transcript Release Factor levels in fat
Time frame: Prior to fasting and at the end of the 72-hour fast in healthy participants and participants with NAFLD
Urine and serum ketosis
Time frame: Daily during the 72-hour fast for healthy participants and participants with NAFLD
Hepatic fat content
Time frame: Before and after the 72-hour fast or hypocaloric diet in participants with NAFLD
change in serum triglyceride levels
Time frame: following fructose and glucose ingestion
change in glucose and insulin levels
Time frame: following fructose and glucose ingestion
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center