Relation of Obesity With Frequency of Meals (MST 0557)

NCT00229255 | Completed

• 1 other identifier: MST-0557
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Insulin Resistance; Fatty Liver

Keywords

Non-Alcoholic hepatic steatosis

Outcome Measures

Primary Outcomes (1)

• 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.

  days 8,9,11 41 and 42

Secondary Outcomes (1)

• 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.

  days 1-42

Study Arms (2)

high frequency meals group

ACTIVE COMPARATOR

High carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.

Other: high frequency of meals

twice-a -day meals

ACTIVE COMPARATOR

high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks

Other: twice a day meals

Interventions

high frequency of meals OTHER

high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.

high frequency meals group

twice a day meals OTHER

high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.

twice-a -day meals

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals
• Age between 18-45 years
• Body mass index (BMI) between 18.5 - 24.9

You may not qualify if:

• 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 magnetic resonance imaging (MRI) including pacemakers, surgical clips, metallic implants, neuromuscular- skeletal stimulators and internal orthopedic screws or rods.

Sponsors & Collaborators

• Rockefeller University: lead
• Cornell University: collaborator

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Fatty Liver

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Markus Stoffel, MD, PHD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: March 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

US (1)