High Fat - High Protein Diet in the Treatment of Obesity

Obesity Clinical Trial

Official title:

Exploratory Feasibility Study: High Fat/Protein Diet in the Treatment of Obesity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00299273
• Other study ID #: JBR-0583
• Status: Terminated
• Phase: N/A
• First received: March 2, 2006
• Last updated: June 4, 2015
• Start date: March 2006
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• 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 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.

Description:

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 eat an average American diet. This is followed by the 6 week weight loss period where subjects will be put on a low calorie high fat/protein diet. During the weight loss period, calories will be cut by 50% 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 subjects will be encouraged to maintain their 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 each phase of the study.

Other known NCT identifiers

• NCT00503373

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) of 30 to 34.9 or

• BMI of 25 to 29.9 and a waist circumference > 88cm (35in)

• Pre-menopausal-

Exclusion Criteria:

• High Blood Pressure

• High Cholesterol

• Diabetes

• Anemia

• Liver disease

• Kidney disease

• HIV positive

• Syphilis

• Hepatitis B/C positive

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Low calorie high fat/protein diet
6 weeks of caloric restriction (50%) on a high fat/protein diet

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral adipose tissue		after 6 weeks	No
Secondary	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	No