Relation of Obesity With Frequency of Meals (MST 0557) - Full Text View

Sponsor:	Rockefeller University
Collaborator:	Cornell University
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00229255

Purpose

The purpose of this study is to test the relationship between frequency of meals and hepatic fat content and insulin sensitivity. We, the researchers at Rockefeller University, hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance.

This is a 6 week inpatient study.

Condition	Intervention
Obesity Insulin Resistance Fatty Liver	Other: high frequency of meals Other: twice a day meals

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Relation of Obesity With Frequency of Meals (MST 0557)

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

We will determine total body insulin sensitivity with the help of the hyperinsulinemic-euglycemic clamp. We will also assess hepatic steatosis by conducting MRI scans on our subjects. [ Time Frame: days 8,9,11 41 and 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight, waist and hip circumference, fasting glucose and insulin, serum ketones, lipids and lipoproteins including VLDL and apolipoprotien B100, liver function tests, serum adiponectin (marker for insulin resistance), and measures of hunger. [ Time Frame: days 1-42 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2005
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
high frequency meals group: Active Comparator High carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.	Other: high frequency of meals high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
twice-a -day meals: Active Comparator high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks	Other: twice a day meals high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.

Detailed Description:

The hypothesis will be tested by studying two groups of normal subjects who will receive a defined weight maintenance diet: one group will be given meals twice a day and other group will be given eight meals (snacks) per day. At the beginning of the study period and after 4 weeks following the specified frequency of meals, the study subjects will have their whole body insulin sensitivity and hepatic fat content measured by the euglycemic-hyperinsulinemic clamp and MRI of the liver, respectively.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy individuals
Age between 18-45 years
Body mass index (BMI) between 18.5 - 24.9

Exclusion Criteria:

Diabetes mellitus
Chronic drug treatment for any medical condition like hypertension or hyperlipidemia, hyperthyroidism or taking weight control medications.
Inability to give informed consent.
Inability to give contact information including permanent residence or provide evidence of stable living environment for the study period.
Active weight reduction of more than 7 pounds in the last 3 months.
History of bleeding or blood clotting disorders.
Pregnancy or breast-feeding in the women.
History of anaphylaxis or anaphylactoid-like reaction as a result of food allergies.
HIV or hepatitis B and C positive subjects.
Subjects with hemoglobin < 8.5 gm/dl.
Abnormal liver function test (ALT, AST, alkaline phosphate, LDH, GGT or total bilirubin).
Serum creatinine or BUN greater than the upper limit of the normal, serum albumin less than 3.5g/dl, or proteinuria 1+ or greater.
History of alcohol intake of more than 40 g/day.
Contraindications to magnetic resonance imaging (MRI) including pacemakers, surgical clips, metallic implants, neuromuscular- skeletal stimulators and internal orthopedic screws or rods.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229255

Locations

United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021

Sponsors and Collaborators

Rockefeller University

Cornell University

Investigators

Principal Investigator:

Markus Stoffel, MD, PHD

Rockefeller University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Rockefeller University ( Allegra Grossman, MD )
Study ID Numbers:	MST-0557
Study First Received:	September 27, 2005
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00229255 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rockefeller University:

Non-Alcoholic hepatic steatosis

Additional relevant MeSH terms:

Obesity
Liver Diseases
Metabolic Diseases
Fatty Liver
Overweight
Body Weight
Hyperinsulinism

Signs and Symptoms
Digestive System Diseases
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 09, 2009