Ignite Creation Date:
2024-05-06 @ 3:38 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02337231
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2014-12-17
Brief Title:
Botanical Oils Study to Determine Genetic Differences in the Way Your Body Processes Fats in Edible Oils
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Role of Fatty Acid Desaturases FADS Polymorphisms in Determining the In Vivo Metabolism of Polyunsaturated Fatty Acids PUFAs in Botanical Oils in Humans
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized controlled cross-over clinical trial of borage oil vs soybean oil to determine whether the metabolism andor 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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50AT002782-08 | NIH | None | httpsreporternihgovquickSearchP50AT002782-08 |