Effect of Diet Composition on Weight Change and Metabolic Parameters

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Tennessee.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01642849
First received: July 3, 2012
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Obesity
Inflammation
Dietary Supplement: high protein diet
Dietary Supplement: high carbohydrate diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Diet Composition on Weight Change and Metabolic Parameters

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Effect of Diet Composition on Weight Change and Metabolic Parameters [ Time Frame: 6 months on High Protein or High Carbohydrate diet ] [ Designated as safety issue: No ]
    Outcome Measures: The effect of a high protein diet or a high carbohydrate diet provided to subjects for 6 months on metabolic parameters.


Secondary Outcome Measures:
  • Effect of Diet Composition on Weight Change and Metabolic Parameters [ Time Frame: 6 months on a high protein or high carbohydrate diet ] [ Designated as safety issue: No ]
    The effect of a high protein or high carbohydrate diet supplied to subjects for 6 months on weight loss.


Estimated Enrollment: 24
Study Start Date: January 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high protein diet
12 subjects will be place on a high protein diet
Dietary Supplement: high protein diet
6 months on HP diet
Dietary Supplement: high carbohydrate diet
12 subjects will be placed on a hig carbohydrate diet for 6 months
Experimental: high carbohydrate diet
12 subjects will be put on a high carbohydrate diet for 6 months
Dietary Supplement: high carbohydrate diet
12 subjects will be placed on a hig carbohydrate diet for 6 months

Detailed Description:

Population: Recruit and study 24 pre-menopausal women with the following 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 Design: The study is designed to determine the follow

To compare the effects of high protein (HP) versus high carbohydrate (HC) diet during energy restriction on weight loss, body composition (lean and fat body mass) and bone mineral density in a free living out patient setting.

To assess the effects of HP versus HC diets on metabolic parameters including insulin sensitivity, protein and muscle break down, lipoprotein metabolism and basal metabolic rate.

Procedures: SCREENING VISIT 1:Individuals fulfilling the inclusion and exclusion criteria will be invited for the first screening visit (VS1). A brief study overview will be given along with a brief history and physical examination, height and weight measurements and blood drawn for chemistry profile and and Oral Glucose Tolerance Test (OGTT) to determine normal glucose handling.

SCREENING VISIT 2 (VS2):Individuals fulfilling all the criteria will be contacted and invited for a second screening visit (VS2). Block food frequency questionnaire to assess baseline dietary profile will be given along with a pre-study orientation with the help of a nutritionist.

SCREENING VISIT 3 (VS3): At the final screening visit (VS3) the food diary will be reviewed. Individuals will be randomized into one of the two diet groups using a randomization table. Participants will be asked to participate in the additional studies of euglycemic hyperinsulinemic clamp and indirect calorimetry.

Study participants will either follow a HP or a HC diet for 6 months, where all food is supplied to them. Randomization will be performed using a randomization table. HP diet will be based on 30% Kcals from protein, 40% Kcals from carbohydrate (CHO) and 30% Kcals from fat. In contrast, HC diet will comprise 15% Kcals from protein, 55% Kcals from CHO and 30% Kcals from fat. Subjects will come in weekly for their food pick up and weight checks.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642849

Contacts
Contact: Frankie B Stentz, M.S., Ph.D. 901-448-5803 fstentz@uthsc.edu
Contact: Abbas E Kitabchi, M.D. 901-448-5803

Locations
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: Frankie B Stentz, M.S., Ph.D.    901-448-5803    fstentz@uthsc.edu   
Principal Investigator: Abbas E Kitabchi, M.D.         
Sub-Investigator: Frankie B Stentz, M.S., Ph.D.         
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Frankie B. Stentz, M.S., Ph.D. University of Tennessee
  More Information

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01642849     History of Changes
Other Study ID Numbers: 03-07996-FB, 1-09-CR-32
Study First Received: July 3, 2012
Last Updated: July 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
high protein diet
high carbohydrate diet
weight loss
oxidative stress
inflammation
cardiovascular risk factors

Additional relevant MeSH terms:
Inflammation
Body Weight Changes
Pathologic Processes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014