Official Title: “Relation of Obesity With Frequency of Meals (MST 0557)”

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 Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment

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.

Intervention(s) in this Clinical Trial

• Other: high frequency of 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: high frequency meals group
  • 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

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Rockefeller University

Overall Clinical Trial Officials and Contacts

Markus Stoffel, MD, PHD Principal Investigator Rockefeller University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00229255

Study ID Number: MST-0557

ClinicalTrials.gov Identifier: NCT00229255

Health Authority: United States: Institutional Review Board