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Completed

NCT Number: NCT00229255

Relation of Obesity With Frequency of Meals (MST 0557)

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rockefeller University Hospital

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals
  • Age between 18-45 years
  • Body mass index (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 magnetic resonance imaging (MRI) including pacemakers, surgical clips, metallic implants, neuromuscular- skeletal stimulators and internal orthopedic screws or rods.

Treatment and study plan

high frequency of meals

Other

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

twice a day meals

Other

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

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.

    Time frame: 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.

    Time frame: days 1-42

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Collaborators

  • Cornell University

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 29, 2005
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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