Genetic Differences of Lipid Metabolism/Healthy SubjectsNCT02337231
Botanical Oils Study to Determine Genetic Differences in the Way Your Body Processes Fats in Edible Oils
A study testing soybean oil and borage oil in people with Genetic Differences of Lipid Metabolism/Healthy Subjects, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Differences of Lipid Metabolism/Healthy Subjects
- What is being tested?
- soybean oil and borage oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2014to 15 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
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.
Read the 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.
- Being tested
- soybean oil and borage oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soybean oil and borage oilDietary supplement
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| GG genotype | 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. Receives: Dietary Supplement: soybean oil and borage oil |
| GT genotype | 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. Receives: Dietary Supplement: soybean oil and borage oil |
| TT genotype | 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. Receives: Dietary Supplement: soybean oil and borage oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL
Measured: 16-week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start24 Jun 2014
- Primary completion15 Dec 2015
- Study completion15 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic Differences of Lipid Metabolism/Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Floyd H. Chilton, Ph.D., Principal investigator, Wake Forest Health SciencePriscilla Ivester, M.S., Study chair, Wake Forest Health ScienceTammy Lee, M.S., Study chair, Wake Forest Health ScienceSusan Sergeant, Ph.D., Study director, Wake Forest Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337231
- Sponsor's protocol ID
- IRB00025085
- Other IDs
- P50AT002782-08
- Status last verified
- Aug 2018
- First submitted
- 17 Dec 2014
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study recruitment has just been completed. Samples are beginning to be analysed and data will be shared when available
Publications
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.
PubMed 32167131
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02337231
- Acronym / sponsor ID
- IRB00025085
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Study start
- 24 Jun 2014 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 15 Dec 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GG genotype | Other | Dietary Supplement: soybean oil and borage oilHealthy 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. |
| GT genotype | Other | Dietary Supplement: soybean oil and borage oilHealthy 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. |
| TT genotype | Other | Dietary Supplement: soybean oil and borage oilHealthy 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soybean oil and borage oilAlso: Botanical oilCompare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs. | Dietary supplement | GG genotype, GT genotype, TT genotype |
Primary outcome
Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL
Time frame: 16-week study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 32167131Sergeant 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.
- Individual participant dataSharing planned: Yes. Study recruitment has just been completed. Samples are beginning to be analysed and data will be shared when available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Floyd H. Chilton, Ph.D. principal investigator
Wake Forest Health Science
Priscilla Ivester, M.S. study chair
Wake Forest Health Science
Tammy Lee, M.S. study chair
Wake Forest Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soybean oil and borage oil in people with Genetic Differences of Lipid Metabolism/Healthy Subjects, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL (time frame: 16-week study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02337231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.