Overview

This trial is active, not recruiting.

Condition genetic differences of lipid metabolism/healthy subjects
Treatment soybean oil and borage oil
Sponsor Wake Forest Baptist Health
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date June 2014
End date December 2016
Trial size 66 participants
Trial identifier NCT02337231, P50AT002782-08, Pending

Summary

A randomized, controlled, cross-over clinical trial of borage oil vs soybean oil to determine whether the metabolism and/or impact of medium chain-polyunsaturated fatty acids (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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Other)
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.
soybean oil and borage oil Botanical oil
Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.
(Other)
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.
soybean oil and borage oil Botanical oil
Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.
(Other)
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.
soybean oil and borage oil Botanical oil
Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.

Primary Outcomes

Measure
Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL
time frame: 16-week study

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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

Additional Information

Official title Role of Fatty Acid Desaturase(s) (FADS) Polymorphisms in Determining the In Vivo Metabolism of Polyunsaturated Fatty Acids (PUFAs) in Botanical Oils in Humans.
Principal investigator Floyd H. Chilton, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Wake Forest Baptist Health.