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Completed

NCT Number: NCT00123240

High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)

The purpose of this study is to compare the ability of low calorie high carbohydrate and low calorie high fat/protein diets to decrease abdominal fat in overweight and obese subjects. The investigators will also test the effects of these diets on secondary outcomes including body composition, fluid and electrolyte balance, lipids and lipoproteins, blood pressure, arterial compliance, glucose and insulin metabolism, bone turnover, and measures of satiety.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rockefeller University

New York, 10021, United States

About this study

Participation in this study requires 2 screening visits to the outpatient clinic, and if participants qualify, 10 inpatient study weeks.

Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study. The first 2 weeks consist of a weight stabilization period, during which subjects will be required to consume an average American diet. This is followed by the 6 week weight loss period where subjects will be randomized to either a low calorie high carbohydrate or a low calorie high fat/protein diet. On both diets there will be a 50% calorie deficit compared to the weight stabilization period. This will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight. Appropriate adjustments will be made to keep the subject's weight stable.

During the entire inpatient study, subjects will consume one multivitamin per day (Centrum, always complete, from A to Zinc) and one iron supplement per day. In addition, unlimited access to zero calorie liquids (water/diet soda) will be available and will be encouraged to maintain one's usual activity level.

Females of reproductive age, need to make sure that they do not become pregnant during the inpatient study. Urine will be tested for pregnancy once during the stabilization and weight maintenance phases of the study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Man or a woman with a body mass index (BMI) of 30 to 34.9
  • Man with a BMI of 25 to 29.9 with a waist circumference > 102cm (40in)
  • Woman with a BMI of 25 to 29.9 with a waist circumference > 88cm (35in)

Exclusion criteria

  • High Blood Pressure
  • High Cholesterol
  • Diabetes
  • HIV positive
  • Syphilis
  • Hepatitis B/C positive

Treatment and study plan

Low calorie high carbohydrate diet

Behavioral

65% carbohydrate, 15% protein, 20% fat (7% SFA, 8% MFA, 4% PUFA), P/S 0.63, 152 mg cholesterol/1500 kcal

Low calorie high fat/protein diet

Behavioral

High Fat/Protein Diet: 10% carbohydrate, 25% protein, 65% fat (26% SFA, 25% MFA, 9% PUFA), P/S 0.33, 458 mg cholesterol/1500 kcal

Primary outcomes

  1. Visceral adipose tissue

    Time frame: days 12, 68

Secondary outcomes

  1. Body composition

    Time frame: days 12, 68

  2. Blood pressure

    Time frame: days 11 and 67

  3. Insulin glucose metabolism

    Time frame: days 13, 15 69, 71

  4. Bone turnover

    Time frame: days 14, 70

  5. Measures of satiety

    Time frame: once a week

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2005
Registry last updated
Jan 11, 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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