The Effect of Prolonged Fasting and Hypocaloric Diet on FGF-21 Levels - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):	Jody Dushay, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00968747

Purpose

The purpose of this study is to examine how fasting or hypocaloric diet affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue.

This study will have three arms, referred to as Study A, Study B, and Study C.

Studies A and B will 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. For Study B, participants will also have two MRIs, one prior to and one at the end of the fast. Study A will include healthy adults and study B will include obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease (NAFLD).

Study C will examine the effect of low-calorie diet on FGF-21 levels. Study C will involve a hypocaloric diet that will be designed to achieve 3-5% weight loss. Study C will include 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 study will look at the effect of 72 hours of fasting (not eating) on levels of proteins that are involved in metabolism. These proteins will be measured in blood and fat tissue. The investigators' hypothesis is that fasting will cause changes in these proteins.

Condition	Intervention
Metabolism Fasting Non-alcoholic Fatty Liver Disease (NAFLD)	Behavioral: Fasting Behavioral: Diet

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	The Effect of Prolonged Fasting and Hypocaloric Diet on FGF-21 Levels

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Fibroblast Growth Factor 21 levels in serum and fat [ Time Frame: Prior to and at the end of the 72-hour fast or hypocaloric diet ] [ Designated as safety issue: No ]
Study Arms A & B: Prior to the fast and at the end of the 72-hour fast. Study Arm C: Prior to the weight loss and after the weight loss.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Urine and serum ketosis [ Time Frame: Daily during the 72-hour fast for healthy participants and participants with NAFLD ] [ Designated as safety issue: No ]
Hepatic fat content [ Time Frame: Before and after the 72-hour fast or hypocaloric diet in participants with NAFLD ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A. Fasting (Healthy). No longer recruiting. Participants will fast for 72 hours during an inpatient stay at the Beth Israel Deaconess Medical Center in Boston, MA. During the fast, participants will receive only water and vitamins. 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 will fast for 72 hours and may consume only water and vitamins.
Experimental: B. Fasting (NAFLD) 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 fast for 72 hours and may consume only water and vitamins.
Experimental: C. Hypocaloric diet (NAFLD) 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 follow a low-calorie diet until they lose 3-5% of their body weight.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

72-hour fast in healthy volunteers (Study Arm A):

Inclusion Criteria:

Age 18-50 years
Body Mass Index 21-26 kg/m^2
Ability to give informed consent
Ability to follow verbal and written instructions in English

Exclusion Criteria:

Type 1 or Type 2 diabetes mellitus diagnosed according to the American Diabetes Association criteria
Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
Tobacco, marijuana, or intravenous drug use within 1 year of screening visit
Recent weight change (>3 kg within 6 months of screening visit)
Malignancy treated with chemotherapy within past 3 years
History of depression, psychosis, or other psychiatric illness requiring hospitalization
History of hyperthyroidism
Renal insufficiency (creatinine clearance < 50 ml/min)
Transaminases > 2X above the normal range
Known liver disease
Pregnancy within 12 months of screening visit
Lactation within 12 months of screening visit
Failure to use medically approved contraceptive methods (oral contraceptive, 2 barrier methods, surgical sterilization)
History of an eating disorder (anorexia, bulimia, or laxative abuse)
History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
New diagnosis of hypothyroidism within 1 year of screening visit or change in dose of thyroid hormone within 3 months of screening visit
History of alcohol abuse within the past 3 years
History of keloid formation
History of allergy to lidocaine or marcaine
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:

Age 18-60
BMI 25-45 kg/m^2
Known nonalcoholic fatty liver disease based on liver biopsy
Ability to give informed consent
Ability to follow verbal and written instructions in English

Exclusion Criteria:

Type I diabetes mellitus diagnosed according to the American Diabetes Association criteria or Type II diabetes mellitus with A1c > 7.5% or taking metformin or thiazolidinediones
Coronary Heart Disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
Uncontrolled hypertension (BP > 150/90 mmHg on or off antihypertensive medication)
Tobacco, marijuana, or intravenous drug use within 1 year of screening visit
Recent weight change (> 3 kg within 6 months of screening visit)
Malignancy treated with chemotherapy within the past 3 years
History of depression, psychosis, or other psychiatric illness requiring hospitalization
History of hypo or hyperthyroidism
Renal insufficiency (creatinine clearance < 50 ml/min)
Pregnancy within 12 months of screening visit
Lactation within 12 months of screening visit
Failure to use medically approved contraceptive methods (oral contraceptive, 2 barrier methods, surgical sterilization)
History of an eating disorder (anorexia, bulimia, or laxative abuse)
History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
New diagnosis of hypo or hyperthyroidism within 1 year of screening visit or change in dose of thyroid hormone within 3 months of screening visit
History of alcohol abuse within the past 3 years
Cardiac pacemaker or aneurysm clips
Metal implants in the body (pins, plates, shrapnel, intact bullets, IUD)
Claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968747

Contacts

Contact: Jody Dushay, MD

617-735-3281

jdushay@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Sub-Investigator: Eleftheria Maratos-Flier, MD
Sub-Investigator: Patricia Chui, MD, PhD
Sub-Investigator: Emilie Mitten
Sub-Investigator: Tahereh Ghorbani, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Jody Dushay, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Jody Dushay, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00968747 History of Changes
Other Study ID Numbers:	2009P-000073
Study First Received:	July 31, 2009
Last Updated:	December 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Fasting
Fast
Metabolism
healthy
diet
study
manipulation
dietary
FGF21

Fibroblast growth factor
PTRF
Polymerase 1 and transcript release factor
adipose
fat
blood
inpatient
outpatient
NAFLD

Additional relevant MeSH terms:

Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012