A to Z Study Follow-up: Collection of DNA Data From Bucca... | NCT00866151

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

NCT00866151

Sponsor

Interleukin Genetics, Inc.

Status

Unknown status

Last Update Posted

Mar 20, 2009Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Weight Management
Diet Conditions
Dietary Recommendations
Overweight Management
Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
14895

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jun 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

Mar 19, 2009

First Submission Date that Met QC Criteria

Mar 19, 2009

First Posted Date

Mar 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2009

Last Update Posted Date

Mar 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Label	Type	Description	Intervention Names
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)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Type	Date	Date Unknown
Release	Mar 30, 2015
Reset	Apr 9, 2015
Release	Sep 8, 2015
Reset	Oct 7, 2015

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 30, 2015			Apr 9, 2015
Sep 8, 2015

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D009765	Obesity
D015431	Weight Loss