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Relation of Obesity With Frequency of Meals (MST 0557)

This study is ongoing, but not recruiting participants.

Sponsored by: Rockefeller 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
Behavioral: Frequency of meals

MedlinePlus related topics:   Obesity   

U.S. FDA Resources

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

Further study details as provided by Rockefeller University:

Estimated Enrollment:   50
Study Start Date:   March 2005

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:

  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.
  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

Investigators
Principal Investigator:     Markus Stoffel, MD, PHD     Rockefeller University    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   MST-0557
First Received:   September 27, 2005
Last Updated:   July 3, 2008
ClinicalTrials.gov Identifier:   NCT00229255
Health Authority:   United States: Institutional Review Board

Keywords provided by Rockefeller University:
Non-Alcoholic hepatic steatosis  

Study placed in the following topic categories:
Morphine
Obesity
Liver Diseases
Metabolic Diseases
Fatty Liver
Overweight
Body Weight
Hyperinsulinism
Signs and Symptoms
Digestive System Diseases
Nutrition Disorders
Overnutrition
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2008




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