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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Interleukin Genetics, Inc.

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.

Condition or disease
Weight Management Diet Conditions Dietary Recommendations Overweight Management Obesity

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs
Study Start Date : August 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : September 2009

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)

Primary Outcome Measures :
  1. The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Buccal swabs are collected by Stanford and sent to Interleukin Genetics for genotyping.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00866151

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United States, California
Stanford University
Stanford, California, United States, 94305-5401
Sponsors and Collaborators
Interleukin Genetics, Inc.
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Principal Investigator: Christopher Gardner, PhD Stanford University
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Responsible Party: Karen Shaver / Director of Clinical Operations, Interleukin Genetics Inc., Identifier: NCT00866151    
Other Study ID Numbers: ILI-08-108WMGTP
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: March 20, 2009
Last Verified: March 2009
Keywords provided by Interleukin Genetics, Inc.:
genetic biomarker
molecular diagnostics
overweight management
weight management
weight reduction
single nucleotide polymorphisms
Additional relevant MeSH terms:
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Body Weight