NCT00123240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

5.8 years

First QC Date

July 19, 2005

Last Update Submit

January 10, 2012

Conditions

Obesity

Keywords

overweightobesediet

Outcome Measures

Primary Outcomes (1)

  • Visceral adipose tissue

    days 12, 68

Secondary Outcomes (5)

  • Body composition

    days 12, 68

  • Blood pressure

    days 11 and 67

  • Insulin glucose metabolism

    days 13, 15 69, 71

  • Bone turnover

    days 14, 70

  • Measures of satiety

    once a week

Study Arms (2)

High Fat/Protein Diet

ACTIVE COMPARATOR
Behavioral: Low calorie high fat/protein diet

High Carbohydrate Diet

ACTIVE COMPARATOR
Behavioral: Low calorie high carbohydrate diet

Interventions

Low calorie high carbohydrate dietBEHAVIORAL

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

High Carbohydrate Diet
Low calorie high fat/protein dietBEHAVIORAL

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

High Fat/Protein Diet

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jan L. Breslow, MD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Study Start

July 1, 2004

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

US(1)