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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NOT_YET_RECRUITING
NA
12 participants
INTERVENTIONAL
2025-01-16
2026-03-28
Brief Summary
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Detailed Description
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1. 40 g ground flaxseed, untreated;
2. 40 g ground flaxseed, roasted before grinding;
3. 40 g intact whole flaxseed;
4. 28 g flaxseed hulls;
5. 0 g flaxseed.
Venous blood will be collected at the following time points: 0 (before consumption of test product), 15, 30, 45, 60, 75, 90, 120, 150, 180 min.
Urine will be collected prior to consumption of test product and 180 min.
Primary endpoints: 1) Peak blood level of cyanide and incremental area under the curve (iAUC) for cyanide in blood over a 3h postprandial period. Secondary endpoint: 1) cyanogenic glycoside and thiocyanate concentrations in plasma and urine over a 3h postprandial period.
Tertiary endpoints: 1) metabolic profile in plasma and urine over 3 h postprandial period.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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No Flax Product
175 g yogurt containing no flax product
0 g Flax
175 g yogurt with no flax product
40 g whole ground flaxseed
175 g yogurt with 40 g whole ground flaxseed
40 g whole ground flaxseed
175 g yogurt with 40 g whole ground flaxseed
40 g roasted then ground whole flaxseed
175 g yogurt with 40 g roasted then ground whole flaxseed
40 g roasted then ground whole flaxseed
175 g yogurt with 40 g roasted then ground whole flaxseed
40 g of whole intact flaxseeds
175 g yogurt with 40 g of whole intact flaxseeds
40 g of whole intact flaxseeds
175 g yogurt with 40 g of whole intact flaxseeds
28 g flax hulls
175 g yogurt with 28 g flax hulls
28 g flax hulls
175 g yogurt with 28 g flax hulls
Interventions
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0 g Flax
175 g yogurt with no flax product
40 g whole ground flaxseed
175 g yogurt with 40 g whole ground flaxseed
40 g roasted then ground whole flaxseed
175 g yogurt with 40 g roasted then ground whole flaxseed
40 g of whole intact flaxseeds
175 g yogurt with 40 g of whole intact flaxseeds
28 g flax hulls
175 g yogurt with 28 g flax hulls
Eligibility Criteria
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Inclusion Criteria
2. Willing to provide informed consent;
3. Willing/able to comply with the requirements of the study.
Exclusion Criteria
2. Medical history of disease that is currently under treatment;
3. Active treatment for any type of cancer within 1 year prior to study start;
4. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks;
5. Plasma concentration of vitamin B12 \< 148 pmol/L;
6. Complete blood count outside normal range;
7. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥3 times the upper limit of normal (ULN));
8. Fasting blood glucose ≥6.1 mmol/L and/or HbA1c ≥6.0%;
9. Fasting plasma total cholesterol \>7.8 mmol/L;
10. Fasting plasma HDL \<0.9 mmol/L;
11. Fasting plasma LDL \>5.0 mmol/L;
12. Fasting plasma triglycerides \>2.3 mmol/L;
13. Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg;
14. Major surgery within the last 3 months;
15. Smoking, use of tobacco, vape or cannabis (within the last week);
16. Allergies to flaxseed or yogurt;
17. Aversion or unwillingness to eat study foods;
18. Participation in another clinical trial, current or in the past 4 weeks
18 Years
ALL
Yes
Sponsors
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Agriculture and Agri-Food Canada
OTHER_GOV
St. Boniface Hospital
OTHER
Responsible Party
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Dr. Heather Blewett
Principle Investigator
Principal Investigators
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Heather Blewett, PhD
Role: PRINCIPAL_INVESTIGATOR
Agriculture and Agri-Food Canada
Locations
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I. H. Asper Clinical Research Institute
Winnipeg, Manitoba, Canada
Countries
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Central Contacts
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Facility Contacts
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Heather J Blewett, PhD
Role: backup
Véronique J Barthet, PhD
Role: backup
Michel Aliani, PhD
Role: backup
Lovemore Malunga, PhD
Role: backup
References
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Abraham K, Buhrke T, Lampen A. Bioavailability of cyanide after consumption of a single meal of foods containing high levels of cyanogenic glycosides: a crossover study in humans. Arch Toxicol. 2016 Mar;90(3):559-74. doi: 10.1007/s00204-015-1479-8. Epub 2015 Feb 24.
Agbor-Egbe T, Lape Mbome I. The effects of processing techniques in reducing cyanogen levels during the production of some Cameroonian cassava foods. Journal of Food Composition and Analysis. 2006 Jun;19(4):354-63.
Carlsson L, Mlingi N, Juma A, Ronquist G, Rosling H. Metabolic fates in humans of linamarin in cassava flour ingested as stiff porridge. Food Chem Toxicol. 1999 Apr;37(4):307-12. doi: 10.1016/s0278-6915(99)00015-0.
Cressey P, Reeve J. Metabolism of cyanogenic glycosides: A review. Food Chem Toxicol. 2019 Mar;125:225-232. doi: 10.1016/j.fct.2019.01.002. Epub 2019 Jan 4.
Cressey P, Saunders D, Aupaau F. Evaluation of food safety risks associated with foods containing cyanogenic glycosides. New Zealand Food Safety Technical Paper No: 2022/29. 2022 Nov.
Diaz-Rueda P, Morales de Los Rios L, Romero LC, Garcia I. Old poisons, new signaling molecules: the case of hydrogen cyanide. J Exp Bot. 2023 Oct 13;74(19):6040-6051. doi: 10.1093/jxb/erad317.
EFSA Panel on Contaminants in the Food Chain (CONTAM); Schrenk D, Bignami M, Bodin L, Chipman JK, Del Mazo J, Grasl-Kraupp B, Hogstrand C, Hoogenboom LR, Leblanc JC, Nebbia CS, Nielsen E, Ntzani E, Petersen A, Sand S, Vleminckx C, Wallace H, Benford D, Brimer L, Mancini FR, Metzler M, Viviani B, Altieri A, Arcella D, Steinkellner H, Schwerdtle T. Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels. EFSA J. 2019 Apr 11;17(4):e05662. doi: 10.2903/j.efsa.2019.5662. eCollection 2019 Apr.
Gleadow RM, Moller BL. Cyanogenic glycosides: synthesis, physiology, and phenotypic plasticity. Annu Rev Plant Biol. 2014;65:155-85. doi: 10.1146/annurev-arplant-050213-040027. Epub 2014 Feb 24.
Joint FAO/WHO Expert Committee on Food Additives (JECFA). Safety evaluation of certain food additives and contaminants. WHO food additives series; 65. 2012
Mazza G and Oomah BD. Flaxseed, dietary fiber, and cyanogens. In: "Flaxseed in human nutrition", Editors: Cunnane, S.C. and Thompson, L.U., AOCS Press, 1995 56-81.
Muir AD, Westcott ND. Quantitation of the lignan secoisolariciresinol diglucoside in baked goods containing flax seed or flax meal. J Agric Food Chem. 2000 Sep;48(9):4048-52. doi: 10.1021/jf990922p.
Ngudi DD, Kuo YH, Lambein F. Cassava cyanogens and free amino acids in raw and cooked leaves. Food Chem Toxicol. 2003 Aug;41(8):1193-7. doi: 10.1016/s0278-6915(03)00111-x.
Parikh M, Netticadan T, Pierce GN. Flaxseed: its bioactive components and their cardiovascular benefits. Am J Physiol Heart Circ Physiol. 2018 Feb 1;314(2):H146-H159. doi: 10.1152/ajpheart.00400.2017. Epub 2017 Nov 3.
Yulvianti M, Zidorn C. Chemical Diversity of Plant Cyanogenic Glycosides: An Overview of Reported Natural Products. Molecules. 2021 Jan 30;26(3):719. doi: 10.3390/molecules26030719.
Related Links
Access external resources that provide additional context or updates about the study.
New Zealand Food Safety Authority. Cyanogenic glycosides -Information sheet.
Schneider B. Activity of β-glucosidase in plants with high content of cyanogenic glycosides as important factor determining their toxicity. Toxicology Letters. 2014 229, S170-S170
Other Identifiers
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4030/4687
Identifier Type: -
Identifier Source: org_study_id