Recruiting

Diet Composition

Sponsor:

University of Tennessee

Code:

NCT01642849

Conditions

Obesity

Inflammation

Eligibility Criteria

Sex: Female

Age: 20 - 50

Healthy Volunteers: Accepted

Interventions

high protein diet

high carbohydrate diet

Study Details

Brief summary:

This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on weight loss and other metabolic parameters.

Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity have been well established. The detrimental effects of obesity on cardiovascular, metabolic and psychological parameters as well as the excess cost to the national health budget are astounding. One way of treatment and prevention of obesity has been the use of diet and exercise. In the absence of well-established superiority of one diet over another, different scientifically unproven diets are in common use. A palatable diet providing satiety as well as all essential nutrients may go a long way in treating over-weight individuals. Another factor has been the long-term adherence to such weight loss regimens, which in general have been poor. Protein diets have been known to provide greater satiety and reduced energy intake than carbohydrate diets, but definite long-term studies are sparse. For this study the investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP diet and 12 on HC diet), and compare their weight loss and changes in metabolic parameters between the two diets.

Conditions

Obesity

Inflammation

Study ID

NCT01642849

Start date

Jan, 2009

Status verified date

Jul, 2012

Completion date

Jun, 2013

Anticipated

Primary completion date

Jan, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age range 20 yrs to 50 yrs,
  • BMI > 30 kg/m2 to < 55 kg/m2
  • Fasting glucose < 110 mg/dl and 120 minute OGTT < 170 mg/dl glucose

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: high protein diet

12 subjects will be place on a high protein diet

experimental: high carbohydrate diet

12 subjects will be put on a high carbohydrate diet for 6 months

Interventions

high protein diet

6 months on HP diet

high carbohydrate diet

12 subjects will be placed on a hig carbohydrate diet for 6 months

Primary outcome measure

  • Effect of Diet Composition on Weight Change and Metabolic Parameters [ Time Frame: 6 months on High Protein or High Carbohydrate diet ]

Central Contacts and Locations

Central contacts

Frankie B Stentz, M.S., Ph.D.

901-448-5803fstentz@uthsc.edu

Abbas E Kitabchi, M.D.

901-448-5803

Locations

University of Tennessee Health Science Center

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

Frankie B Stentz, M.S., Ph.D.

901-448-5803fstentz@uthsc.edu

Principal Investigator:

Abbas E Kitabchi, M.D.

More Information

Sponsor

University of Tennessee

Last update posted

Jul 17, 2012

Last verified

Jul, 2012

Keywords

  • high protein diet
  • high carbohydrate diet
  • weight loss
  • oxidative stress
  • inflammation
  • cardiovascular risk factors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2012-07-17.