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Relation of Obesity With Frequency of Meals (MST 0557)

Primary Purpose

Obesity, Insulin Resistance, Fatty Liver

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high frequency of meals
twice a day meals
Sponsored by
Rockefeller University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Non-Alcoholic hepatic steatosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rockefeller University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

high frequency meals group

twice-a -day meals

Arm Description

High carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.

high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks

Outcomes

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.

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.

Full Information

First Posted
September 27, 2005
Last Updated
May 31, 2012
Sponsor
Rockefeller University
Collaborators
Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00229255
Brief Title
Relation of Obesity With Frequency of Meals (MST 0557)
Official Title
Relation of Obesity With Frequency of Meals (MST 0557)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockefeller University
Collaborators
Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance, Fatty Liver
Keywords
Non-Alcoholic hepatic steatosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high frequency meals group
Arm Type
Active Comparator
Arm Description
High carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
Arm Title
twice-a -day meals
Arm Type
Active Comparator
Arm Description
high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks
Intervention Type
Other
Intervention Name(s)
high frequency of meals
Intervention Description
high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
Intervention Type
Other
Intervention Name(s)
twice a day meals
Intervention Description
high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Stoffel, MD, PHD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Relation of Obesity With Frequency of Meals (MST 0557)

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