Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations

Obesity Clinical Trial

Official title:

Comparison of Body Fat Reduction in Overweight and Obese Subjects Utilizing Personalized Low-Fat Meal Plans vs. Non-Personalized Low-Fat Meal Plans.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00487344
• Other study ID #: CF-01-D-0001
• Status: Recruiting
• Phase: Phase 1
• First received: June 15, 2007
• Last updated: July 2, 2007
• Start date: June 2007
• Est. completion date: November 2007

Study information

• Verified date: May 2007
• Source: Central FITT, Inc
• Contact: Stacy D Buzan, MS
• Phone: 405-503-2759
• Email: oktrial[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the use of personalized low-fat meal plans vs. non-personalized low-fat meal plans and the results in body fat reduction in overweight and obese subjects 25 to 45 years of age.

Compensation to Eligible Participants:

1. FREE Nutritional Services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00.

2. Each eligible participant will receive compensation for mileage directly related to this study up to 35 miles at the 2007 IRS Business Mileage Reimbursement Rate for medical purposes of $0.20 per mile. This compensation will be provided to each eligible participant in the form of a complimentary Wal-mart Gift Card in the amount of $7.00, contingent upon his or her completion in the study.

Description:

Study Rationale: This experiment on the effect that the use of personalized low-fat meal plans has on body fat reduction is important for several reasons. First, the details of this research study may equip the public with knowledge to select quality nutrition programs for weight loss responsibly. Second, it may encourage the wellness and fitness community to reconsider the practice of providing clientele with non-personalized meal plans for weight loss, which are not usually designed by accredited dietetic professionals. Third, this study may benefit dietetic professionals by opening the lines of communication between the wellness community and the dietetic community regarding standards of care, and protecting the public by dispelling harmful and erroneous nutrition advice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Between 25 to 45 years of age

• Classified as overweight or obese with body mass index (BMI) measurement between 25 and 50

• Limited to minor chronic health

Exclusion Criteria:

• Individuals with the following health conditions:

• Food allergies

• Food intolerances

• Cancer

• Debilitating joint conditions such as Degenerative Joint Disease (DJD) and Degenerative Disk Disease (DDD)

• Diabetes Mellitus receiving insulin therapy

• Kidney problems

• Menopause

• Polycystic ovarian syndrome (PCOS)

• Currently pregnant or breast feeding

• Using diuretics, chromium, and/or diet pills

• Participants must:

• Live in the following Oklahoma Counties:

• Canadian, Cleveland, Logan, Lincoln, Oklahoma, and Pottawatomie

• Will to travel to Edmond and Oklahoma City, Oklahoma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Procedure:
• Non-Personalized Meal Planning

• Personalized Meal Planning and Dietetic Consultation

Locations

Country	Name	City	State
United States	Central FITT Inc	Edmond	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Central FITT, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre and Post-Bioelectrical Impedance Body Fat Analysis		2 months