HealthyNCT01516125
Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing
An observational study of Healthy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to screen healthy African American and Caucasian persons for specific differences in genes that control how fats are processed in the body. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 17 Apr 2019
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Caucasian or African American adults between 21 and 65 years of age
Who may be able to join
- Be Caucasian or African American between 21-65 years of age
- Be healthy and free of any major illness
- Be a nonsmoker
- Have an intact gallbladder
- Have TG < 150 and blood pressure less than 130/90
- Must be willing to be re-contacted for future studies
Who cannot join
- Not have: myocardial infarction, vascular surgery or stroke within the past year
- Not be taking niacin, more than 100 mg aspirin/day or montelukast allergy medications
- BMI equal to or greater than 30 or less than 19
- Fasting glucose greater than 125 mg/dl
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of this research study is to screen healthy African American and Caucasian persons for specific differences in genes that control how fats are processed in the body.
Read the detailed description
Healthy African American and Caucasian persons will be screened for specific differences in genes that control how fats are processed in the body. Persons with the needed genotypes will be added to a database of healthy persons who may be asked to join a larger study comparing differences in diet on lipid metabolism and inflammatory biomarkers as well as future studies. A key hypothesis for the larger study is that variations in genes involved in lipid metabolism play a role in determining levels of long chain polyunsaturated fatty acids (LC-PUFAs).
- Conditions
- Healthy
- Keywords
- healthy adult, genetic variation, botanical oils, polyunsaturated fatty acid, fish oil, fat metabolism, Genetic variation of fat metabolism in healthy adults
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 |
|---|---|---|
| Screening only - no intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster
Measured: up to 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startSep 2011
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS), University of Arizona
- Responsible party
- Sponsor
- Investigators
- Susan Sergeant, Ph.D., Principal investigator, Wake Forest University Heath Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516125
- Sponsor's protocol ID
- IRB00016822
- Other IDs
- P50AT002782
- Status last verified
- Mar 2023
- First submitted
- 11 Jan 2012
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a screening (one visit) to recruit healthy people for genotyping and re-contact for future studies
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing
- ClinicalTrials.gov ID
- NCT01516125
- Acronym / sponsor ID
- IRB00016822
- Conditions
- Healthy
- Keywords
- healthy adult, genetic variation, botanical oils, polyunsaturated fatty acid, fish oil, fat metabolism, Genetic variation of fat metabolism in healthy adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS), University of Arizona
- Study start
- Sep 2011 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 24 Jan 2012 (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 purpose of this research study is to screen healthy African American and Caucasian persons for specific differences in genes that control how fats are processed in the body.
Detailed description
Healthy African American and Caucasian persons will be screened for specific differences in genes that control how fats are processed in the body. Persons with the needed genotypes will be added to a database of healthy persons who may be asked to join a larger study comparing differences in diet on lipid metabolism and inflammatory biomarkers as well as future studies. A key hypothesis for the larger study is that variations in genes involved in lipid metabolism play a role in determining levels of long chain polyunsaturated fatty acids (LC-PUFAs).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening only - no intervention | – | – |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian or African American adults between 21 and 65 years of age
Key inclusion criteria (6 listed)
- Be Caucasian or African American between 21-65 years of age
- Be healthy and free of any major illness
- Be a nonsmoker
- Have an intact gallbladder
- Have TG < 150 and blood pressure less than 130/90
Key exclusion criteria (5 listed)
- Not have: myocardial infarction, vascular surgery or stroke within the past year
- Not be taking niacin, more than 100 mg aspirin/day or montelukast allergy medications
- BMI equal to or greater than 30 or less than 19
- Fasting glucose greater than 125 mg/dl
- Pregnancy
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
Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster
Time frame: up to 52 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No. This is a screening (one visit) to recruit healthy people for genotyping and re-contact for future studies
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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.
Susan Sergeant, Ph.D. principal investigator
Wake Forest University Heath Sciences
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 Healthy, run by Wake Forest University Health Sciences 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 30 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster (time frame: up to 52 months). 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 30 Nov 2023.