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Relation of Obesity With Frequency of Meals (MST 0557)

This study has been completed.
Sponsor:
Collaborator:
Cornell University
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00229255
First received: September 27, 2005
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Relation of Obesity With Frequency of Meals (MST 0557)

Resource links provided by NLM:

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 ]

Enrollment: 22
Study Start Date: March 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00229255     History of Changes
Other Study ID Numbers: MST-0557
Study First Received: September 27, 2005
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Non-Alcoholic hepatic steatosis

Additional relevant MeSH terms:
Fatty Liver
Insulin Resistance
Obesity
Liver Diseases
Digestive System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013