Relation of Obesity With Frequency of Meals (MST 0557)
This study is currently recruiting patients.
Verified by Rockefeller University July 2006
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 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
MedlinePlus related topics: Metabolic Syndrome X; Obesity
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:
Expected Total Enrollment: 50
Study start: March 2005
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 - 45 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
Healthy individuals
Age between 18-45 years
BMI between 18.5 – 24.9
Exclusion Criteria:
Diabetes Mellitus
Chronic drug treatment for any medical condition like hypertension or hyperlipidemia, hyperthyroidism or taking weight control medications.
Inability to give informed consent.
Inability to give contact information including permanent residence or provide evidence of stable living environment for the study period.
Active weight reduction of more than 7 pounds in the last 3 months.
History of bleeding or blood clotting disorders.
Pregnancy or breast-feeding in the women.
History of anaphylaxis or anaphylactoid-like reaction as a result of food allergies.
HIV or hepatitis B and C positive subjects.
Subjects with hemoglobin <8.5 gm/dl.
Abnormal Liver function test (ALT, AST, Alkaline phosphate, LDH, GGT or Total Bilirubin).
Serum creatinine or BUN greater than the upper limit of the normal, serum albumin less than 3.5g/dl, or proteinuria 1+ or greater.
History of alcohol intake of more than 40 g/day.
Contraindications to MRI including pacemakers, surgical clips, metallic implants, neuromuscular- skeletal stimulators and internal orthopedic screws or rods.
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Location and Contact Information
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
Allegra Grossman, MD 212-327-7018
agrossman@rockefeller.edu
Markus Stoffel, MD, PHD, Principal Investigator
Study chairs or principal investigators
Markus Stoffel, MD, PHD, Principal Investigator, Rockefeller University
More Information
http://www.rucares.org:8001/rucares/admin/form.php?id
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
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