Role of Polyunsaturated Fatty Acids (PUFA)-Gene Interactions in Heath Disparities
NCT ID: NCT02962128
Last Updated: 2022-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2016-11-29
2021-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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High Linoleic Acid (LA) Diet
European Americans (genotypes: TT, GT \& GG) and African Americans (genotypes: GT \& GG) at rs173537will be randomly assigned to a high LA diet (10% energy) based on a randomized block design with 5 strata defined by race and genotype combinations.
High Linoleic Acid (LA) Diet
Volunteers will be randomly assigned to consumption of a high \[10% energy\] LA-containing diet for 12 weeks.
Low Linoleic Acid (LA) Diet
European Americans (genotypes: TT, GT \& GG) and African Americans (genotypes: GT \& GG) at rs173537will be randomly assigned to a low LA diet (2.5% energy) based on a randomized block design with 5 strata defined by race and genotype combinations.
Low Linoleic Acid (LA) Diet
Volunteers will be randomly assigned to consumption of a low \[2.5% energy\] LA-containing diet for 12 weeks.
Interventions
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High Linoleic Acid (LA) Diet
Volunteers will be randomly assigned to consumption of a high \[10% energy\] LA-containing diet for 12 weeks.
Low Linoleic Acid (LA) Diet
Volunteers will be randomly assigned to consumption of a low \[2.5% energy\] LA-containing diet for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Must agree to adhere to dietary intervention requirements during the entire 12-week study period
* Be willing to participate for the whole study
* Agree not to take any PUFA-based dietary supplements during the study
* Agree not to take interfering medications during the duration of the study
* Agree to allow samples to be stored for future use
* Self-identify as European American or African American
Exclusion Criteria
* use of tobacco products (smoked, smokeless, electronic) within the last six months
* Currently pregnant or lactating. Potential female subjects are asked in the telephone screening if they are pregnant or plan to become pregnant in the next year. Those answering in the affirmative are excluded. We will include in the Institutional Review Board (IRB) protocol and consent that subjects agree to use a reliable method of birth control during the time they are in the study.
* Having a current or recent history of eating disorders
* Having an allergy to safflower or, flaxseed or olive oils.
* fasting triglycerides (TG) greater than 150 mg/dl, as measured by Lab Corp at screening
* BP greater than 140/90 , as measured by a CRU nurse, at screening
* BMI equal to or greater than 30 or less than 19, as measured at screening
* fasting glucose greater than 125 mg/dl, as measured by Lab Corp at screening
* use of aspirin (\>100 mg /day), NSAIDS or oral corticosteroids
* use of montelukast-type of allergy medications
* use of statins, niacin or fibrates or other lipid lowering medications
* use of botanical/fish (PUFA-containing) oil or dietary supplements for one month prior to joining the study .
* individuals not self-identifying as European American or African American
* individuals self-identifying as Hispanic
* Individuals of vulnerable populations, including children, will not be recruited for this study
* having an hsCRP measurement in excess of 3.0 at Visit 1
21 Years
65 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Office of Dietary Supplements (ODS)
NIH
University of Arizona
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Susan Sergeant, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Countries
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References
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Chen ST. Regulation of research: is it a drug trial or a supplement trial? Fitoterapia. 2011 Jan;82(1):14-6. doi: 10.1016/j.fitote.2010.11.011. Epub 2010 Nov 10.
Schaeffer L, Gohlke H, Muller M, Heid IM, Palmer LJ, Kompauer I, Demmelmair H, Illig T, Koletzko B, Heinrich J. Common genetic variants of the FADS1 FADS2 gene cluster and their reconstructed haplotypes are associated with the fatty acid composition in phospholipids. Hum Mol Genet. 2006 Jun 1;15(11):1745-56. doi: 10.1093/hmg/ddl117. Epub 2006 May 2.
Mathias RA, Sergeant S, Ruczinski I, Torgerson DG, Hugenschmidt CE, Kubala M, Vaidya D, Suktitipat B, Ziegler JT, Ivester P, Case D, Yanek LR, Freedman BI, Rudock ME, Barnes KC, Langefeld CD, Becker LC, Bowden DW, Becker DM, Chilton FH. The impact of FADS genetic variants on omega6 polyunsaturated fatty acid metabolism in African Americans. BMC Genet. 2011 May 20;12:50. doi: 10.1186/1471-2156-12-50.
Sergeant S, Hugenschmidt CE, Rudock ME, Ziegler JT, Ivester P, Ainsworth HC, Vaidya D, Case LD, Langefeld CD, Freedman BI, Bowden DW, Mathias RA, Chilton FH. Differences in arachidonic acid levels and fatty acid desaturase (FADS) gene variants in African Americans and European Americans with diabetes or the metabolic syndrome. Br J Nutr. 2012 Feb;107(4):547-55. doi: 10.1017/S0007114511003230. Epub 2011 Jul 4.
Malerba G, Schaeffer L, Xumerle L, Klopp N, Trabetti E, Biscuola M, Cavallari U, Galavotti R, Martinelli N, Guarini P, Girelli D, Olivieri O, Corrocher R, Heinrich J, Pignatti PF, Illig T. SNPs of the FADS gene cluster are associated with polyunsaturated fatty acids in a cohort of patients with cardiovascular disease. Lipids. 2008 Apr;43(4):289-99. doi: 10.1007/s11745-008-3158-5. Epub 2008 Mar 5.
Xie L, Innis SM. Genetic variants of the FADS1 FADS2 gene cluster are associated with altered (n-6) and (n-3) essential fatty acids in plasma and erythrocyte phospholipids in women during pregnancy and in breast milk during lactation. J Nutr. 2008 Nov;138(11):2222-8. doi: 10.3945/jn.108.096156.
Lattka E, Koletzko B, Zeilinger S, Hibbeln JR, Klopp N, Ring SM, Steer CD. Umbilical cord PUFA are determined by maternal and child fatty acid desaturase (FADS) genetic variants in the Avon Longitudinal Study of Parents and Children (ALSPAC). Br J Nutr. 2013 Apr 14;109(7):1196-210. doi: 10.1017/S0007114512003108. Epub 2012 Aug 9.
Bokor S, Dumont J, Spinneker A, Gonzalez-Gross M, Nova E, Widhalm K, Moschonis G, Stehle P, Amouyel P, De Henauw S, Molnar D, Moreno LA, Meirhaeghe A, Dallongeville J; HELENA Study Group. Single nucleotide polymorphisms in the FADS gene cluster are associated with delta-5 and delta-6 desaturase activities estimated by serum fatty acid ratios. J Lipid Res. 2010 Aug;51(8):2325-33. doi: 10.1194/jlr.M006205. Epub 2010 Apr 28.
Ramsden CE, Zamora D, Leelarthaepin B, Majchrzak-Hong SF, Faurot KR, Suchindran CM, Ringel A, Davis JM, Hibbeln JR. Use of dietary linoleic acid for secondary prevention of coronary heart disease and death: evaluation of recovered data from the Sydney Diet Heart Study and updated meta-analysis. BMJ. 2013 Feb 4;346:e8707. doi: 10.1136/bmj.e8707.
Chilton FH, Murphy RC, Wilson BA, Sergeant S, Ainsworth H, Seeds MC, Mathias RA. Diet-gene interactions and PUFA metabolism: a potential contributor to health disparities and human diseases. Nutrients. 2014 May 21;6(5):1993-2022. doi: 10.3390/nu6051993.
Mathias RA, Pani V, Chilton FH. Genetic Variants in the FADS Gene: Implications for Dietary Recommendations for Fatty Acid Intake. Curr Nutr Rep. 2014 Jun;3(2):139-148. doi: 10.1007/s13668-014-0079-1.
Ramsden CE, Faurot KR, Zamora D, Suchindran CM, MacIntosh BA, Gaylord S, Ringel A, Hibbeln JR, Feldstein AE, Mori TA, Barden A, Lynch C, Coble R, Mas E, Palsson O, Barrow DA, Mann DJ. Targeted alteration of dietary n-3 and n-6 fatty acids for the treatment of chronic headaches: a randomized trial. Pain. 2013 Nov;154(11):2441-2451. doi: 10.1016/j.pain.2013.07.028. Epub 2013 Jul 22.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB00038046
Identifier Type: -
Identifier Source: org_study_id
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