Relation of Obesity With Frequency of Meals (MST 0557)

Obesity Clinical Trial

Official title:

Relation of Obesity With Frequency of Meals (MST 0557)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229255
• Other study ID #: MST-0557
• Status: Completed
• Phase: N/A
• First received: September 27, 2005
• Last updated: May 31, 2012
• Start date: March 2005
• Est. completion date: June 2009

Study information

• Verified date: May 2012
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Insulin Resistance
• Obesity

Intervention

Other:
• high frequency of meals
high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
• twice a day meals
high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.

Locations

Country	Name	City	State
United States	Rockefeller University Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No