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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00866151
• Other study ID #: ILI-08-108WMGTP
• Secondary ID: 14895
• Status: Unknown status
• Phase: N/A
• First received: March 19, 2009
• Last updated: March 19, 2009
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2009
• Source: Interleukin Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Interleukin Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI.		1 year
Secondary	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