NCT00299273

Brief Summary

The purpose of this study is to examine the effects of a low calorie high fat/protein diet on body fat and body composition in overweight and obese subjects. The investigators will also test the effects of this diet on secondary outcomes such as: fluid and electrolyte balance, cholesterol, inflammation, sugar and insulin metabolism, fat hormones, blood pressure and feelings of fullness.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

8.8 years

First QC Date

March 2, 2006

Last Update Submit

June 4, 2015

Conditions

Obesity

Keywords

Obesity;Low calorie high fat/protein diet;Low-carbohydrate dietWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Visceral adipose tissue

    after 6 weeks

Secondary Outcomes (1)

  • Body composition, fluid and electrolyte balance, lipids/lipoprotein metabolism, markers of inflammation, glucose and insulin metabolism, fat hormones, blood pressure and measures of satiety.

    after 6 weeks

Study Arms (1)

Low calorie high fat/protein diet

EXPERIMENTAL

Low calorie high fat/protein diet

Behavioral: Low calorie high fat/protein diet

Interventions

Low calorie high fat/protein dietBEHAVIORAL

6 weeks of caloric restriction (50%) on a high fat/protein diet

Low calorie high fat/protein diet

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) of 30 to 34.9 or
  • BMI of 25 to 29.9 and a waist circumference \> 88cm (35in)
  • Pre-menopausal-

You may not qualify if:

  • High Blood Pressure
  • High Cholesterol
  • Diabetes
  • Anemia
  • Liver disease
  • Kidney disease
  • HIV positive
  • Syphilis
  • Hepatitis B/C positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rockefeller University Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Jan L. Breslow, MD

    The Rockefeller University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 6, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)