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

Sponsor

Interleukin Genetics, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00866151

Collaborator

(none)

150

Enrollment

Location

Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated 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 :

Aug 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

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

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. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)