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

NCT00866151 | Unknown

• 2 other identifiers: ILI-08-108WMGTP14895
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• 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

Study Arms (1)

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)

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Interleukin Genetics, Inc.: lead

Study Sites (1)

Stanford University

Stanford, California, 94305-5401, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs are collected by Stanford and sent to Interleukin Genetics for genotyping.

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Christopher Gardner, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 20, 2009

Record last verified: 2009-03

Locations

US (1)