Clinical trial NCT00866151: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weight Management
Diet Conditions
Dietary Recommendations
Overweight Management
Obesity
Keywords: genetic biomarker
biomarker
molecular diagnostics
genes
genetics
overweight management
weight management
weight reduction
SNPs
single nucleotide polymorphisms
Lead sponsor: Interleukin Genetics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Christopher Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
References: