Weight ManagementNCT00866151
A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs
An observational study of Weight Management and Diet Conditions, run by Interleukin Genetics, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Management, Diet Conditions, Dietary Recommendations
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University
Stanford, California, 94305-5401
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Interleukin Genetics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher Gardner, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866151
- Sponsor's protocol ID
- ILI-08-108WMGTP
- Other IDs
- 14895
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs
- ClinicalTrials.gov ID
- NCT00866151
- Acronym / sponsor ID
- ILI-08-108WMGTP
- Conditions
- Weight Management, Diet Conditions, Dietary Recommendations, Overweight Management, Obesity
- Keywords
- genetic biomarker, biomarker, molecular diagnostics, genes, genetics, overweight management, weight management, weight reduction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Interleukin Genetics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (10 listed)
- BMI (body mass index): 27-40 kg/m2
- Gender: Women only
- Age: 25-50
- Menopausal status: pre-menopausal
- Weight stable for last 2-months
Key exclusion criteria (11 listed)
- Hypertension
- Diabetes (type 1 or 2) or history of gestational diabetes
- Heart disease diagnosis
- Renal or lever disease
- Active neoplasms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI.
Time frame: 1 year
1 secondary outcome
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.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Gardner, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Management and Diet Conditions, run by Interleukin Genetics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2009.