Effect of Flax in Yogurt on Blood Cyanide Levels

NCT06491095 | Not Yet Recruiting

• 1 other identifier: 4030/4687
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled, cross-over post-prandial trial in healthy human volunteers will be conducted at the IH Asper Institute to determine the effect whole ground flaxseed, roasted then ground whole flaxseed, whole intact flaxseed and flaxseed hulls mixed into yogurt on blood cyanide levels.

Conditions

Healthy

Keywords

Flax; Blood Cyanide

Outcome Measures

Primary Outcomes (2)

• Peak blood level of cyanide

  highest concentration of cyanide during 180 min postprandial period

  180 minutes

• iAUC blood cyanide

  incremental area under the curve for cyanide from 0-180 min

  180 min

Secondary Outcomes (1)

• Cyanogenic glycoside and thiocyanate concentrations in plasma and urine

  180 minutes

Other Outcomes (1)

• Concentration of metabolites in blood and urine

  180 minutes

Study Arms (5)

No Flax Product

OTHER

175 g yogurt containing no flax product

Dietary Supplement: 0 g Flax

40 g whole ground flaxseed

EXPERIMENTAL

175 g yogurt with 40 g whole ground flaxseed

Dietary Supplement: 40 g whole ground flaxseed

40 g roasted then ground whole flaxseed

EXPERIMENTAL

175 g yogurt with 40 g roasted then ground whole flaxseed

Dietary Supplement: 40 g roasted then ground whole flaxseed

40 g of whole intact flaxseeds

EXPERIMENTAL

175 g yogurt with 40 g of whole intact flaxseeds

Dietary Supplement: 40 g of whole intact flaxseeds

28 g flax hulls

EXPERIMENTAL

175 g yogurt with 28 g flax hulls

Dietary Supplement: 28 g flax hulls

Interventions

0 g Flax DIETARY_SUPPLEMENT

175 g yogurt with no flax product

No Flax Product

40 g whole ground flaxseed DIETARY_SUPPLEMENT

175 g yogurt with 40 g whole ground flaxseed

40 g whole ground flaxseed

40 g roasted then ground whole flaxseed DIETARY_SUPPLEMENT

175 g yogurt with 40 g roasted then ground whole flaxseed

40 g roasted then ground whole flaxseed

40 g of whole intact flaxseeds DIETARY_SUPPLEMENT

175 g yogurt with 40 g of whole intact flaxseeds

40 g of whole intact flaxseeds

28 g flax hulls DIETARY_SUPPLEMENT

175 g yogurt with 28 g flax hulls

28 g flax hulls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy adult, 18 years or older;
• Willing to provide informed consent;
• Willing/able to comply with the requirements of the study.

You may not qualify if:

• Pregnant or lactating;
• Medical history of disease that is currently under treatment;
• Active treatment for any type of cancer within 1 year prior to study start;
• 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;
• Plasma concentration of vitamin B12 \< 148 pmol/L;
• Complete blood count outside normal range;
• Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥3 times the upper limit of normal (ULN));
• Fasting blood glucose ≥6.1 mmol/L and/or HbA1c ≥6.0%;
• Fasting plasma total cholesterol \>7.8 mmol/L;
• Fasting plasma HDL \<0.9 mmol/L;
• Fasting plasma LDL \>5.0 mmol/L;
• Fasting plasma triglycerides \>2.3 mmol/L;
• Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg;
• Major surgery within the last 3 months;
• Smoking, use of tobacco, vape or cannabis (within the last week);

Sponsors & Collaborators

• St. Boniface Hospital: lead
• Agriculture and Agri-Food Canada: collaborator

Study Sites (1)

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (14)

• 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.

  PMID: 25708890 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10418947 BACKGROUND

• 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.

  PMID: 30615957 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 37586035 BACKGROUND

• 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.

  PMID: 32626287 BACKGROUND

• 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.

  PMID: 24579992 BACKGROUND

• Joint FAO/WHO Expert Committee on Food Additives (JECFA). Safety evaluation of certain food additives and contaminants. WHO food additives series; 65. 2012

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10995312 BACKGROUND

• 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.

  PMID: 12842188 BACKGROUND

• 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.

  PMID: 29101172 BACKGROUND

• 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.

  PMID: 33573160 BACKGROUND

Related Links

• 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

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Heather Blewett, PhD

  Agriculture and Agri-Food Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Blewett, PhD

CONTACT

204-237-2954; hblewett@sbrc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: July 8, 2024
• Study Start: January 16, 2025
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CA (1)