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A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Interleukin Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00866151
First received: March 19, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 19, 2009
March 19, 2009
August 2008
June 2009   (final data collection date for primary outcome measure)
The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
The SECONDARY objective is to explore the association of single nucleotide polymorphisms (SNPs) with other metabolic parameters, such as blood lipid profile, insulin level, and other cardiovascular risk factors. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
 
 
 
A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs
A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs

The goal of this study is to determine the association between genotypes and diet. The weight and weight loss data are already available from the previously completed study called: A to Z Study - Benefits and Risks of Alternative Weight Loss Strategies - A Clinical Trial, which was performed from 2003-2005 at Stanford University. In the present study, Interleukin Genetics will obtain DNA samples from the previously enrolled study subjects to investigate genetic influence of the response to macronutrient compositions of low caloric diets to weight loss.

Interleukin Genetics has derived, through an extensive search of the scientific literature, a genetic test panel in the area of Weight Management (WM), which includes the genes that have been shown to affect body weight. These genes have been associated with elevated risk for obesity.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Retention:   Samples With DNA
Description:

Buccal swabs are collected by Stanford and sent to Interleukin Genetics for genotyping.
Probability Sample

The study population for the A to Z study are premenopausal women who are overweight (BMI 27-40 kg/m2) but in otherwise good general health. Overweight participants with potentially confounding health conditions are excluded (eg., hypertension, diabetes, heart disease, cancer). Children were not included in this study. The participants were asked to agree to a random assignment to dietary plans.
  • Weight Management
  • Diet Conditions
  • Dietary Recommendations
  • Overweight Management
  • Obesity
 
1
Previously enrolled subjects in the "Benefits and Risks of Alternative Weight Loss Strategies - a Clinical Trial", which was run at Stanford 2003-2005. (A to Z Study)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
150
September 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI (body mass index): 27-40 kg/m2
  • Gender: Women only
  • Age: 25-50
  • Menopausal status: pre-menopausal
  • Weight stable for last 2-months
  • Not on a weight loss plan
  • No ethnic restrictions
  • No plans to move from the area over the next 6-months
  • Willing to accept random assignment
  • Possess English speaking and reading skills to understand and complete forms such as informed consent and study evaluation

Exclusion Criteria:

  • Hypertension
  • Diabetes (type 1 or 2) or history of gestational diabetes
  • Heart disease diagnosis
  • Renal or lever disease
  • Active neoplasms
  • Pregnant, lactating, within 6-months of birth, or planning to become pregnant in the next 6-months
  • Hyperthyroidism, unless treated and under control
  • Medications known to affect weight / energy expenditure
  • Excessive alcohol intake (self-reported, > 3 drinks/day)
  • Postmenopausal, including surgical menopause
  • Currently under psychiatric care, or severely clinically depressed (>17 on Beck Inventory)
Female
25 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00866151
ILI-08-108WMGTP, 14895
No
Karen Shaver / Director of Clinical Operations, Interleukin Genetics Inc.,
Interleukin Genetics, Inc.
 
Principal Investigator: Christopher Gardner, PhD Stanford University
Interleukin Genetics, Inc.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP