Obesity Discussion Forums - View Single Post - Relation of Obesity With Frequency of Meals Study

Obesity Discussion · 03-25-06, 07:31 PM

Relation of Obesity With Frequency of Meals

This study is currently recruiting patients.
Verified by Rockefeller University September 2005

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

Further study details as provided by Rockefeller University:

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.

-

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: December 8, 2005
Record first received: September 27, 2005
ClinicalTrials.gov Identifier: NCT00229255
Health Authority: United States: Food and Drug Administration

03-25-06, 07:31 PM	#1 (permalink)
Obesity Discussion Administrator Join Date: Jan 2005 Location: Phoenix, AZ Posts: 7,625 Weight Statistics 8/1/2006 Start Date: 185 lb Start Weight: 152 lb Current Weight: 155 lb Goal Weight: -33 lb Weight Loss: 5/1/2007 Goal Date:	Relation of Obesity With Frequency of Meals Study Relation of Obesity With Frequency of Meals This study is currently recruiting patients. Verified by Rockefeller University September 2005 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 Further study details as provided by Rockefeller University: 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. - 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: December 8, 2005 Record first received: September 27, 2005 ClinicalTrials.gov Identifier: NCT00229255 Health Authority: United States: Food and Drug Administration __________________