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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Weight Management, Diet Conditions, Dietary Recommendations, Overweight Management, Obesity

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic biomarker, biomarker, molecular diagnostics, genes, genetics, overweight management, weight management, weight reduction, SNPs, single nucleotide polymorphisms