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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
  Purpose

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
Weight Management
Diet Conditions
Dietary Recommendations
Overweight Management
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Interleukin Genetics, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 150
Study Start Date: August 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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)

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866151

Locations
United States, California
Stanford University
Stanford, California, United States, 94305-5401
Sponsors and Collaborators
Interleukin Genetics, Inc.
Investigators
Principal Investigator: Christopher Gardner, PhD Stanford University
  More Information

No publications provided

Responsible Party: Karen Shaver / Director of Clinical Operations, Interleukin Genetics Inc.,
ClinicalTrials.gov Identifier: NCT00866151     History of Changes
Other Study ID Numbers: ILI-08-108WMGTP, 14895
Study First Received: March 19, 2009
Last Updated: March 19, 2009
Health Authority: United States: Institutional Review Board

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:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013