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

• Conditions: Diet Conditions; Dietary Recommendations; Overweight Management; Weight Management; Obesity

• Registration Number: NCT00866151
• Lead Sponsor: Interleukin Genetics, Inc.

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.

Study Timeline

• Study Start: 2008-08
• Status Verified: 2009-03
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Last Update Submitted: 2009-03-19
• Study First Posted: 2009-03-20
• Last Update Posted: 2009-03-20
• Primary Completion: 2009-06
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States