Other Clinical Trial - Regulation of FGF21 by Nutritional Challenges

Status Completed

Clinical Trial 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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT00968747
Study type	Interventional
Source	Beth Israel Deaconess Medical Center
Contact
Status	Completed
Phase	N/A
Start date	July 2009
Completion date	July 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03754920` - Prolonged Fasting With Meditation and Mild Physical Exercise	N/A
Completed	`NCT05272332` - Gastric Ultrasound Prior to Extubation
Completed	`NCT04247464` - Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients	N/A
Completed	`NCT01067001` - Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study	N/A
Completed	`NCT00757094` - Safety and Feasibility of Fasting While Receiving Chemotherapy	N/A
Completed	`NCT01506713` - Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions	Phase 1
Completed	`NCT04514380` - Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
Completed	`NCT05756868` - The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior	N/A
Completed	`NCT05134207` - The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty	N/A
Completed	`NCT05031598` - Long-term Fasting: Multi-system Adaptations in Humans	N/A
Recruiting	`NCT04501393` - Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients	N/A
Enrolling by invitation	`NCT04027478` - Can Fasting Decrease the Side Effects of Chemotherapy?	N/A
Completed	`NCT05219136` - Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol	N/A
Recruiting	`NCT04625608` - Effect of Premedicant Oral Paracetamol on Gastric Volume and pH	Phase 4
Not yet recruiting	`NCT02562638` - Pre-Procedural Fasting in Cardiac Intervention	N/A
Completed	`NCT01949987` - Does Oral Intake Decreases Postoperative Pain Score in Children	N/A
Completed	`NCT01954836` - Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial	N/A
Completed	`NCT01831700` - Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions	Phase 1
Completed	`NCT01713647` - Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions	Phase 1
Completed	`NCT01721187` - Satiety Effects on the Neural Valuation of Food	N/A