Gender Effects of Dietary Omega-3 Fatty Acids From Plant and Marine Sources on Oxylipins in Healthy Humans
NCT ID: NCT02317588
Last Updated: 2016-03-10
Study Results
Results pending
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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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-12-31
Study Completion Date
2016-02-29
Brief Summary
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This study is single site, double-blind, randomized, cross-over study designed to compare the effects of flax oil and fish oil supplementation on the oxylipin profile in healthy males and females. Eligible participants will complete two (2) Supplementation Phases (flax oil versus fish oil) and will be asked to attend 6 in-person clinic visits (0, 1, 3, 7, 14 and 28 days) for blood and urine collection during each phase. Participants will consume 8 capsules a day for 28 days containing either A) Flax Oil at 4 grams of ALA per day ,in one phase and B) Fish Oil at a dose of 4 grams DHA + 0.8 grams EPA per day in the next phase. Participants will be randomized and blinded and will therefore no know what supplement they are taking in either phase.
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Detailed Description
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This is a single site, double-blind, randomized, crossover study designed to compare the effects of dietary omega-3 fatty acids from flax oil versus fish oil supplementation on oxylipin profiles over time (0 to 4 weeks) and between healthy males and females.
Recruitment will consist of a total of six (6) male and six (6) female participants. Participants will be recruited through advertisement from the local community. The study will be conducted at the Asper Centre for Clinical Research, St. Boniface Hospital. Participants will be asked to provide written informed consent prior to participation in the study. Participants who have provided written consent will be asked to attend an in-patient visit to provide a fasting blood sample. Should the participant be eligible to participate, they will be scheduled for a minimum 6 week Run-in Period, a 4 week Supplementation Phase, a minimum 6 week Wash-out Period and then a second 4 week Supplementation Phase; each Supplementation Phase will have 6 in-person visits (0, 1, 3, 7, 14 and 28 days) to obtain fasting blood and urine samples and for completion of the Study Checklist. During each 4 week Supplementation Phase, participants will consume capsules containing flax oil and at a dose of 4 grams of ALA/day, or capsules containing fish oil and at a dose of 4 grams DHA + 0.8 grams EPA/day. A 3-Day Food Record and Activity Questionnaire will be completed before the Day 0 visit and during week 3 of each Supplementation Phase.
Provision of flax oil or fish oil in capsules will allow this study to be double-blinded. Blinding will reduce potential bias during data collection and evaluation of study endpoints. Both the research team and the participant are blinded from the time of randomization and for the duration of the study. Randomization will be used to avoid bias in the assignment; to increase the likelihood that known and unknown participant characteristics are evenly balanced across the various test groups; and to enhance the validity of statistical comparisons across test groups.
Recruitment will consist of a total of six (6) male and six (6) female participants. Participants will be recruited through advertisement from the local community. The study will be conducted at the Asper Centre for Clinical Research, St. Boniface Hospital. Participants will be asked to provide written informed consent prior to participation in the study. Participants who have provided written consent will be asked to attend an in-patient visit to provide a fasting blood sample. Should the participant be eligible to participate, they will be scheduled for a minimum 6 week Run-in Period, a 4 week Supplementation Phase, a minimum 6 week Wash-out Period and then a second 4 week Supplementation Phase; each Supplementation Phase will have 6 in-person visits (0, 1, 3, 7, 14 and 28 days) to obtain fasting blood and urine samples and for completion of the Study Checklist. During each 4 week Supplementation Phase, participants will consume capsules containing flax oil and at a dose of 4 grams of ALA/day, or capsules containing fish oil and at a dose of 4 grams DHA + 0.8 grams EPA/day. A 3-Day Food Record and Activity Questionnaire will be completed before the Day 0 visit and during week 3 of each Supplementation Phase.
Provision of flax oil or fish oil in capsules will allow this study to be double-blinded. Blinding will reduce potential bias during data collection and evaluation of study endpoints. Both the research team and the participant are blinded from the time of randomization and for the duration of the study. Randomization will be used to avoid bias in the assignment; to increase the likelihood that known and unknown participant characteristics are evenly balanced across the various test groups; and to enhance the validity of statistical comparisons across test groups.
Conditions
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Healthy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Flax Oil
Flax oil 4 grams of ALA per day for 28 days (4 weeks).
Group Type
ACTIVE_COMPARATOR
Flax Oil
Intervention Type
DIETARY_SUPPLEMENT
Participants will consume capsules containing flax oil at a dose of 4 grams of ALA per day (8 capsules a day) with a meal for 28 days (4 weeks).
Fish Oil
Fish oil at a dose of 4 grams DHA + 0.8 grams EPA per day for 28 days (4 weeks).
Group Type
ACTIVE_COMPARATOR
Fish Oil
Intervention Type
DIETARY_SUPPLEMENT
Participants will consume capsules containing fish oil at a dose of 4 grams DHA + 0.8 grams EPA per day (8 capsules) for 28 days (4 weeks).
Interventions
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Flax Oil
Participants will consume capsules containing flax oil at a dose of 4 grams of ALA per day (8 capsules a day) with a meal for 28 days (4 weeks).
Intervention Type
DIETARY_SUPPLEMENT
Fish Oil
Participants will consume capsules containing fish oil at a dose of 4 grams DHA + 0.8 grams EPA per day (8 capsules) for 28 days (4 weeks).
Intervention Type
DIETARY_SUPPLEMENT
Other Intervention Names
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Now Brand Organic Flax Oil
Carlson DHA Gems
Eligibility Criteria
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Inclusion Criteria
Participants must meet the following criteria to be eligible for participation in the study:
1. Male, or non-pregnant, non-lactating premenopausal female, ≥18 and ≤50 years of age;
2. Normal blood lipid profile (total cholesterol \<5.2 mmol/L, LDL-cholesterol \<3.4 mmol/L, HDL-cholesterol \>0.9 mmol/L, triglycerides \<1.7 mmol/L), plasma creatinine \<1.5× upper limit of normal (ULN) where the normal range is 50-97 µmol/L, and glycated hemoglobin \<6%; aspartate transaminase (AST) \<2× ULN where the normal range is 10 - 32 U/L, and alanine transaminase (ALT) \<2× ULN where the normal range is \<25 U/L;
3. Blood pressure \<140/90;
4. Body mass index (BMI) of 18 to 28;
5. Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 months and while participating in the study;
6. Willing to maintain a stable level of activity while participating in the study;
7. Willing to maintain dietary routine and to refrain from consuming omega-3 supplements or omega-3 rich foods (\>0.3 grams ALA/serving, or \>0.1 grams EPA + DHA/serving) from acceptance into the study until the final study visit;
8. Females must have normal menses and can be on birth control;
9. Agrees to not donate blood while participating in the study and for 2 months after participation in the study.
10. Willing to comply with the protocol requirements and procedures;
11. Willing to provide informed consent.
1. Male, or non-pregnant, non-lactating premenopausal female, ≥18 and ≤50 years of age;
2. Normal blood lipid profile (total cholesterol \<5.2 mmol/L, LDL-cholesterol \<3.4 mmol/L, HDL-cholesterol \>0.9 mmol/L, triglycerides \<1.7 mmol/L), plasma creatinine \<1.5× upper limit of normal (ULN) where the normal range is 50-97 µmol/L, and glycated hemoglobin \<6%; aspartate transaminase (AST) \<2× ULN where the normal range is 10 - 32 U/L, and alanine transaminase (ALT) \<2× ULN where the normal range is \<25 U/L;
3. Blood pressure \<140/90;
4. Body mass index (BMI) of 18 to 28;
5. Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 months and while participating in the study;
6. Willing to maintain a stable level of activity while participating in the study;
7. Willing to maintain dietary routine and to refrain from consuming omega-3 supplements or omega-3 rich foods (\>0.3 grams ALA/serving, or \>0.1 grams EPA + DHA/serving) from acceptance into the study until the final study visit;
8. Females must have normal menses and can be on birth control;
9. Agrees to not donate blood while participating in the study and for 2 months after participation in the study.
10. Willing to comply with the protocol requirements and procedures;
11. Willing to provide informed consent.
Exclusion Criteria
Participants will be excluded if they have any of the following:
1. Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system, or a disease condition that has required or currently requires medical treatment;
2. Taking any prescribed medication, regular use of acetylsalicylic acid (e.g. Aspirin), ibuprofen (e.g. Advil) or acetaminophen (e.g. Tylenol) within the last 3 months;
3. Allergy or sensitivity to any of the study product ingredients, such as flax, flax oil, or marine source oils such as fish or shellfish.
4. Cigarette/cigar smoking or use of tobacco products within the past 12 months or during the study;
5. Body weight has not been stable (±3 kg) over the past 6 months;
6. Consumption of \>15 alcoholic beverages per week (according to Canada's Low-Risk Alcohol Drinking Guidelines, 2012) within the last 3 months or while participating in the study;
7. Current (within the past 30 days) bacterial, viral or fungal infection;
8. Unable to obtain blood sample at the screening and/or week 0 visit.
9. Donated or had blood collected in the 2 months prior to participation the study.
1. Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system, or a disease condition that has required or currently requires medical treatment;
2. Taking any prescribed medication, regular use of acetylsalicylic acid (e.g. Aspirin), ibuprofen (e.g. Advil) or acetaminophen (e.g. Tylenol) within the last 3 months;
3. Allergy or sensitivity to any of the study product ingredients, such as flax, flax oil, or marine source oils such as fish or shellfish.
4. Cigarette/cigar smoking or use of tobacco products within the past 12 months or during the study;
5. Body weight has not been stable (±3 kg) over the past 6 months;
6. Consumption of \>15 alcoholic beverages per week (according to Canada's Low-Risk Alcohol Drinking Guidelines, 2012) within the last 3 months or while participating in the study;
7. Current (within the past 30 days) bacterial, viral or fungal infection;
8. Unable to obtain blood sample at the screening and/or week 0 visit.
9. Donated or had blood collected in the 2 months prior to participation the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sponsor Role
collaborator
Manitoba Health Research Council
UNKNOWN
Sponsor Role
collaborator
University of Manitoba
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Carla Taylor, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Site Status
Countries
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Canada
References
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Psychogios N, Hau DD, Peng J, Guo AC, Mandal R, Bouatra S, Sinelnikov I, Krishnamurthy R, Eisner R, Gautam B, Young N, Xia J, Knox C, Dong E, Huang P, Hollander Z, Pedersen TL, Smith SR, Bamforth F, Greiner R, McManus B, Newman JW, Goodfriend T, Wishart DS. The human serum metabolome. PLoS One. 2011 Feb 16;6(2):e16957. doi: 10.1371/journal.pone.0016957.
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BACKGROUND
Schuchardt JP, Schmidt S, Kressel G, Dong H, Willenberg I, Hammock BD, Hahn A, Schebb NH. Comparison of free serum oxylipin concentrations in hyper- vs. normolipidemic men. Prostaglandins Leukot Essent Fatty Acids. 2013 Jul;89(1):19-29. doi: 10.1016/j.plefa.2013.04.001. Epub 2013 May 19.
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Ramsden CE, Ringel A, Feldstein AE, Taha AY, MacIntosh BA, Hibbeln JR, Majchrzak-Hong SF, Faurot KR, Rapoport SI, Cheon Y, Chung YM, Berk M, Mann JD. Lowering dietary linoleic acid reduces bioactive oxidized linoleic acid metabolites in humans. Prostaglandins Leukot Essent Fatty Acids. 2012 Oct-Nov;87(4-5):135-41. doi: 10.1016/j.plefa.2012.08.004. Epub 2012 Sep 5.
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Caligiuri SP, Love K, Winter T, Gauthier J, Taylor CG, Blydt-Hansen T, Zahradka P, Aukema HM. Dietary linoleic acid and alpha-linolenic acid differentially affect renal oxylipins and phospholipid fatty acids in diet-induced obese rats. J Nutr. 2013 Sep;143(9):1421-31. doi: 10.3945/jn.113.177360. Epub 2013 Jul 31.
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Keenan AH, Pedersen TL, Fillaus K, Larson MK, Shearer GC, Newman JW. Basal omega-3 fatty acid status affects fatty acid and oxylipin responses to high-dose n3-HUFA in healthy volunteers. J Lipid Res. 2012 Aug;53(8):1662-9. doi: 10.1194/jlr.P025577. Epub 2012 May 24.
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Harris WS, Mozaffarian D, Rimm E, Kris-Etherton P, Rudel LL, Appel LJ, Engler MM, Engler MB, Sacks F. Omega-6 fatty acids and risk for cardiovascular disease: a science advisory from the American Heart Association Nutrition Subcommittee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Cardiovascular Nursing; and Council on Epidemiology and Prevention. Circulation. 2009 Feb 17;119(6):902-7. doi: 10.1161/CIRCULATIONAHA.108.191627. Epub 2009 Jan 26. No abstract available.
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Czernichow S, Thomas D, Bruckert E. n-6 Fatty acids and cardiovascular health: a review of the evidence for dietary intake recommendations. Br J Nutr. 2010 Sep;104(6):788-96. doi: 10.1017/S0007114510002096. Epub 2010 Jun 4.
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Khaw KT, Friesen MD, Riboli E, Luben R, Wareham N. Plasma phospholipid fatty acid concentration and incident coronary heart disease in men and women: the EPIC-Norfolk prospective study. PLoS Med. 2012;9(7):e1001255. doi: 10.1371/journal.pmed.1001255. Epub 2012 Jul 3.
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MacLean CH, Mojica WA, Morton SC, Pencharz J, Hasenfeld Garland R, Tu W, Newberry SJ, Jungvig LK, Grossman J, Khanna P, Rhodes S, Shekelle P. Effects of omega-3 fatty acids on lipids and glycemic control in type II diabetes and the metabolic syndrome and on inflammatory bowel disease, rheumatoid arthritis, renal disease, systemic lupus erythematosus, and osteoporosis. Evid Rep Technol Assess (Summ). 2004 Mar;(89):1-4. No abstract available.
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Miles EA, Calder PC. Influence of marine n-3 polyunsaturated fatty acids on immune function and a systematic review of their effects on clinical outcomes in rheumatoid arthritis. Br J Nutr. 2012 Jun;107 Suppl 2:S171-84. doi: 10.1017/S0007114512001560.
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Goldberg RJ, Katz J. A meta-analysis of the analgesic effects of omega-3 polyunsaturated fatty acid supplementation for inflammatory joint pain. Pain. 2007 May;129(1-2):210-23. doi: 10.1016/j.pain.2007.01.020. Epub 2007 Mar 1.
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Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.
Reference Type
DERIVED
Gabbs M, Zahradka P, Taylor CG, Aukema HM. Time Course and Sex Effects of alpha-Linolenic Acid-Rich and DHA-Rich Supplements on Human Plasma Oxylipins: A Randomized Double-Blind Crossover Trial. J Nutr. 2021 Mar 11;151(3):513-522. doi: 10.1093/jn/nxaa294.
Reference Type
DERIVED
Related Links
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http://www.ccarm.ca
Canadian Centre for Agri-Food Research in Health and Medicine
Other Identifiers
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B2014:036
Identifier Type: -
Identifier Source: org_study_id
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