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Completed

NCT Number: NCT02337231

Botanical Oils Study to Determine Genetic Differences in the Way Your Body Processes Fats in Edible Oils

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soybean oil and borage oil

Dietary Supplement

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: Botanical oil

Primary outcomes

  1. Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL

    Time frame: 16-week study

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Office of Dietary Supplements (ODS)

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2015
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.