Relation of Obesity With Frequency of Meals (MST 0557)
May 31, 2012 updated by: Rockefeller University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10021
- Rockefeller University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: high frequency meals group
High carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
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high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
|
|
Active Comparator: twice-a -day meals
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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days 8,9,11 41 and 42
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
days 1-42
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Markus Stoffel, MD, PHD, Rockefeller University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 27, 2005
First Submitted That Met QC Criteria
September 27, 2005
First Posted (Estimate)
September 29, 2005
Study Record Updates
Last Update Posted (Estimate)
June 1, 2012
Last Update Submitted That Met QC Criteria
May 31, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MST-0557
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