- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02337231
Botanical Oils Study to Determine Genetic Differences in the Way Your Body Processes Fats in Edible Oils
Role of Fatty Acid Desaturase(s) (FADS) Polymorphisms in Determining the In Vivo Metabolism of Polyunsaturated Fatty Acids (PUFAs) in Botanical Oils in Humans.
Study Overview
Status
Intervention / Treatment
Detailed Description
The study will be a randomized, controlled, cross-over clinical trial of borage oil and soybean oil to determine whether the metabolism and/or impact of MC-PUFAs in botanical oil supplements are changed in relationship to specific genotypes in a SNP (rs174537) strongly associated with FADS1 activity and PUFA metabolism. Subjects previously genotyped at rs174537 will be given supplements and both blood PUFA (serum and erythrocyte membranes), urinary eicosanoids and eicosanoid release from whole blood (leukocyte generation) will be measured as biochemical determinants of genotype impact on supplement metabolism.
To evaluate the effect of genotype at the rs174537 locus on the metabolism of MC-PUFAs in borage and soybean oil to long chain polyunsaturated fatty acids (LC-PUFAs), including arachidonic acid, the investigators will utilize a double blind, randomized, crossover design. There will be three study groups based on the genotype of the healthy volunteer at rs174537. Individuals within each genotype will be consented and screened up to 8 weeks prior to randomization and the start of the intervention. Subjects will be randomized to begin with 4 weeks of either borage oil or soybean oil followed by an 8 week washout period, and then another 4 week period in which they take the second oil. Study visits will occur at 0, 2, and 4 weeks during each oil supplementation period, in addition to the consenting visit, for a total of 7 visits during the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Able to give informed consent
- Must agree to adhere to dietary requirements during the entire study
- Be willing to participate for the whole study
- Be willing to not take PUFA supplements outside of those provided by the study
- Agree not to take interfering medications during the duration of the study
- Agree to allow samples to be stored for future use
Exclusion Criteria:
- May not have diabetes, cancer, heart attack or vascular surgery within the past year, be diagnosed with heart disease, have uncontrolled high blood pressure, history of stroke, atherosclerosis, asthma, multiple sclerosis or chronic joint disease
- Gallbladder removal or gallbladder disease
- Use of tobacco products within the last six months
- Pregnancy or lactation
- Fasting triglycerides greater than 150 mg/dl
- Blood pressure greater than 130/90
- BMI equal to or greater than 30 or less than 19
- Fasting glucose greater than 125 mg/dl
- Have liver function values in the normal range
- Taking greater than 100 mg aspirin/day
- Taking NSAIDS or oral corticosteroids
- Taking montelukast-type allergy medications
- Having a pacemaker or a defibrillator
- Taking lipid lowering medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: GG genotype
Healthy participants with genotype GG at rs174537 will take gel capsules that contain soybean oil (4-weeks) and borage oil (4-weeks) in a crossover study.
|
Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.
Other Names:
|
OTHER: GT genotype
Healthy participants with genotype GT at rs174537 will take gel capsules that contain soybean oil (4-weeks) and borage oil (4-weeks) in a crossover study.
|
Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.
Other Names:
|
OTHER: TT genotype
Healthy participants with genotype TT at rs174537 will take gel capsules that contain soybean oil (4-weeks) and borage oil (4-weeks) in a crossover study.
|
Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL
Time Frame: 16-week study
|
16-week study
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Floyd H. Chilton, Ph.D., Wake Forest Health Science
- Study Chair: Priscilla Ivester, M.S., Wake Forest Health Science
- Study Chair: Tammy Lee, M.S., Wake Forest Health Science
- Study Director: Susan Sergeant, Ph.D., Wake Forest Health Science
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00025085
- P50AT002782-08 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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