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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.

Study Description
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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.
Study Design
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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
Groups and Cohorts
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Group/Cohort
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)


Outcome Measures
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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.

Eligibility Criteria
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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.
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)
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00866151


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305-5401
Sponsors and Collaborators
Interleukin Genetics, Inc.
Investigators
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Principal Investigator: Christopher Gardner, PhD Stanford University
More Information
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Responsible Party: Karen Shaver / Director of Clinical Operations, Interleukin Genetics Inc.,
ClinicalTrials.gov Identifier: NCT00866151    
Other Study ID Numbers: ILI-08-108WMGTP
14895
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
biomarker
molecular diagnostics
genes
genetics
 overweight management
weight management
weight reduction
SNPs
single nucleotide polymorphisms
Additional relevant MeSH terms:
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Overweight
Body Weight