Clinical Trial:Relation of Obesity With Frequency of Meals

The purpose of this study is to test the relationship between frequency of meals and hepatic fat content and insulin sensitivity. We 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.

Condition	Intervention
Obesity Insulin Resistance Non-Alcoholic Hepatic Steatosis	Behavior: Frequency of meals

Further study details as provided by Rockefeller University:

Expected Total Enrollment:  50

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.

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Healthy individuals
2. Age between 18-45 years
3. 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 MRI including pacemakers, surgical clips, metallic implants, neuromuscular- skeletal stimulators and internal orthopedic screws or rods.

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Please refer to this study by ClinicalTrials.gov identifier  NCT00229255

Allegra Grossman, MD      212-327-7018    agrossman@rockefeller.edu

New York
      Rockefeller University Hospital, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Markus Stoffel, MD, PHD,  Principal Investigator,  Rockefeller University   

Study ID Numbers:  MST-0557-0305
Last Updated:  July 24, 2006
Record first received:  September 27, 2005
ClinicalTrials.gov Identifier:  NCT00229255
Health Authority: United States: Food and Drug Administration

Related Articles

 

Research

Eating at Fast-Food Restaurants More Than Twice Per Week Is Associated with More Weight Gain and Insulin Resistance (12/30/2004, National Heart, Lung, and Blood Institute)

Estimated Risks for Developing Obesity in the Framingham Heart Study (10/04/2005, American Heart Association)

Obesity and Arthritis among Baby Boomers (09/01/2005, Arthritis Foundation)

Obesity and Weight Gain Increase Risk for Kidney Stones (01/28/2005, American Medical Association)

Obesity as Compared with Physical Activity in Predicting Risk of Coronary Heart Disease in Women (01/31/2006, American Heart Association)

Obesity Threatens to Cut U.S. Life Expectancy (03/16/2005, National Institute on Aging)

Short- and Long-Term Risks for Middle-Aged Adults Becoming Overweight or Obese (10/04/2005, American College of Physicians)

Treating Obesity: Laparoscopic Gastric Banding Versus a Nonsurgical Weight Loss Program (05/02/2006, American College of Physicians)