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Report for Clinical Trial NCT02337231

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT02337231 Genetic Differences of Lipid Metabolism/Healthy Subjects

1 Interventions

Name: soybean oil and borage oil

Description: Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.

Type: Dietary Supplement

GG genotype GT genotype TT genotype


Primary Outcomes

Measure: Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL

Time: 16-week study

Purpose: Basic Science

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 rs174537

Role of Fatty Acid Desaturase(s) (FADS) Polymorphisms in Determining the In Vivo Metabolism of Polyunsaturated Fatty Acids (PUFAs) in Botanical Oils in Humans.. 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.

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 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 Genetic Differences of Lipid Metabolism/Healthy Subjects 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.



HPO Nodes