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Relation of Obesity With Frequency of Meals (MST 0557)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00229255
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : June 1, 2012
Cornell University
Information provided by (Responsible Party):
Rockefeller University

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.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Fatty Liver Other: high frequency of meals Other: twice a day meals Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Relation of Obesity With Frequency of Meals (MST 0557)
Study Start Date : March 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: high frequency meals group
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.

Active Comparator: twice-a -day meals
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.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00229255

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United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Cornell University
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Principal Investigator: Markus Stoffel, MD, PHD Rockefeller University

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Responsible Party: Rockefeller University Identifier: NCT00229255    
Other Study ID Numbers: MST-0557
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Rockefeller University:
Non-Alcoholic hepatic steatosis
Additional relevant MeSH terms:
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Fatty Liver
Insulin Resistance
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases