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

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ClinicalTrials.gov Identifier: NCT02337231
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Genetic Differences of Lipid Metabolism/Healthy Subjects Dietary Supplement: soybean oil and borage oil Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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.
Actual Study Start Date : June 24, 2014
Actual Primary Completion Date : December 15, 2015
Actual Study Completion Date : December 15, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Dietary Supplement: soybean oil and borage 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 Name: Botanical oil

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.
Dietary Supplement: soybean oil and borage 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 Name: Botanical oil

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.
Dietary Supplement: soybean oil and borage 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 Name: Botanical oil




Primary Outcome Measures :
  1. Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL [ Time Frame: 16-week study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337231


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
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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

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02337231     History of Changes
Other Study ID Numbers: IRB00025085
P50AT002782-08 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study recruitment has just been completed. Samples are beginning to be analysed and data will be shared when available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Borage oil
Antirheumatic Agents