Clinical trial NCT02337231: Botanical Oils Study to Determine Genetic Differences in the Way Your Body Processes Fats in Edible Oils
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Differences of Lipid Metabolism/Healthy Subjects
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Office of Dietary Supplements (ODS)
First posted: 2015-01-13
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL
timeFrame: 16-week study
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest Health Science
name: Floyd H. Chilton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest Health Science
name: Priscilla Ivester, M.S.
role: STUDY_CHAIR
affiliation: Wake Forest Health Science
name: Tammy Lee, M.S.
role: STUDY_CHAIR
affiliation: Wake Forest Health Science
name: Susan Sergeant, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Sergeant S, Hallmark B, Mathias RA, Mustin TL, Ivester P, Bohannon ML, Ruczinski I, Johnstone L, Seeds MC, Chilton FH. Prospective clinical trial examining the impact of genetic variation in FADS1 on the metabolism of linoleic acid- and ɣ-linolenic acid-containing botanical oils. Am J Clin Nutr. 2020 May 1;111(5):1068-1078. doi: 10.1093/ajcn/nqaa023.