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

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ClinicalTrials.gov Identifier: NCT00866151
Recruitment Status : Unknown
Verified March 2009 by Interleukin Genetics, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : March 20, 2009
Last Update Posted : March 20, 2009
Sponsor:
Information provided by:
Interleukin Genetics, Inc.

Tracking Information
First Submitted Date March 19, 2009
First Posted Date March 20, 2009
Last Update Posted Date March 20, 2009
Study Start Date August 2008
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2009)
The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI. [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 19, 2009)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs
Official Title A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Buccal swabs are collected by Stanford and sent to Interleukin Genetics for genotyping.
Sampling Method Probability Sample
Study Population 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.
Condition
  • Weight Management
  • Diet Conditions
  • Dietary Recommendations
  • Overweight Management
  • Obesity
Intervention Not Provided
Study Groups/Cohorts 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 19, 2009)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00866151
Other Study ID Numbers ILI-08-108WMGTP
14895
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karen Shaver / Director of Clinical Operations, Interleukin Genetics Inc.,
Study Sponsor Interleukin Genetics, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Christopher Gardner, PhD Stanford University
PRS Account Interleukin Genetics, Inc.
Verification Date March 2009