HealthyNCT06491095
Effect of Flax in Yogurt on Blood Cyanide Levels
A study testing 0 g Flax, 40 g whole ground flaxseed and 40 g roasted then ground whole flaxseed in people with Healthy, run by St. Boniface Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 0 g Flax, 40 g whole ground flaxseed and 40 g roasted then ground whole flaxseed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jan 2025to 28 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy adult, 18 years or older;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study.
Who cannot join
- 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;
Show all 18Show fewer
- 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);
- Allergies to flaxseed or yogurt;
- Aversion or unwillingness to eat study foods;
- Participation in another clinical trial, current or in the past 4 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
I. H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
Heather J Blewett, PhD, 204-237-2954, hblewett@sbrc.ca
Heather J Blewett, PhD
About this study
Official title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Flaxseed on Blood Cyanide Levels in Healthy Adults
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.
Read the detailed description
Participants will receive yogurt containing the following flaxseed products in a random order:
- 40 g ground flaxseed, untreated;
- 40 g ground flaxseed, roasted before grinding;
- 40 g intact whole flaxseed;
- 28 g flaxseed hulls;
- 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
- Healthy
- Being tested
- 0 g Flax, 40 g whole ground flaxseed, 40 g roasted then ground whole flaxseed, 40 g of whole intact flaxseeds, 28 g flax hulls
- Keywords
- Flax, Blood Cyanide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 g FlaxDietary supplement
175 g yogurt with no flax product
40 g whole ground flaxseedDietary supplement
175 g yogurt with 40 g whole ground flaxseed
40 g roasted then ground whole flaxseedDietary supplement
175 g yogurt with 40 g roasted then ground whole flaxseed
40 g of whole intact flaxseedsDietary supplement
175 g yogurt with 40 g of whole intact flaxseeds
28 g flax hullsDietary supplement
175 g yogurt with 28 g flax hulls
| Study group | Role | What they receive |
|---|---|---|
| No Flax Product | Other | 175 g yogurt containing no flax product Receives: Dietary Supplement: 0 g Flax |
| 40 g whole ground flaxseed | Experimental | 175 g yogurt with 40 g whole ground flaxseed Receives: 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 Receives: 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 Receives: Dietary Supplement: 40 g of whole intact flaxseeds |
| 28 g flax hulls | Experimental | 175 g yogurt with 28 g flax hulls Receives: Dietary Supplement: 28 g flax hulls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak blood level of cyanide
highest concentration of cyanide during 180 min postprandial period
Measured: 180 minutes
iAUC blood cyanide
incremental area under the curve for cyanide from 0-180 min
Measured: 180 min
Secondary outcomes (1)
Cyanogenic glycoside and thiocyanate concentrations in plasma and urine
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start16 Jan 2025 (estimated)
- Primary completion28 Mar 2025 (estimated)
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Dr. Heather Blewett, St. Boniface Hospital
- Investigators
- Heather Blewett, PhD, Principal investigator, Agriculture and Agri-Food Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491095
- Sponsor's protocol ID
- 4030/4687
- Status last verified
- Nov 2024
- First submitted
- 5 Jun 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25708890Agbor-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.
PubMed 10418947Cressey 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.
PubMed 30615957Cressey 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.
PubMed 37586035EFSA 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.
PubMed 32626287Gleadow 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.
PubMed 24579992Joint 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.
PubMed 10995312Ngudi 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.
PubMed 12842188Parikh 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.
PubMed 29101172Yulvianti 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.
PubMed 33573160
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Cross-over Trial Examining the Effect of Flaxseed on Blood Cyanide Levels in Healthy Adults
- ClinicalTrials.gov ID
- NCT06491095
- Acronym / sponsor ID
- 4030/4687
- Conditions
- Healthy
- Keywords
- Flax, Blood Cyanide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- 16 Jan 2025 (estimated)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will receive yogurt containing the following flaxseed products in a random order:
- 40 g ground flaxseed, untreated;
- 40 g ground flaxseed, roasted before grinding;
- 40 g intact whole flaxseed;
- 28 g flaxseed hulls;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No Flax Product | Other | Dietary Supplement: 0 g Flax175 g yogurt containing no flax product |
| 40 g whole ground flaxseed | Experimental | Dietary Supplement: 40 g whole ground flaxseed175 g yogurt with 40 g whole ground flaxseed |
| 40 g roasted then ground whole flaxseed | Experimental | Dietary Supplement: 40 g roasted then ground whole flaxseed175 g yogurt with 40 g roasted then ground whole flaxseed |
| 40 g of whole intact flaxseeds | Experimental | Dietary Supplement: 40 g of whole intact flaxseeds175 g yogurt with 40 g of whole intact flaxseeds |
| 28 g flax hulls | Experimental | Dietary Supplement: 28 g flax hulls175 g yogurt with 28 g flax hulls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Generally healthy adult, 18 years or older;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0 g Flax175 g yogurt with no flax product | Dietary supplement | No Flax Product |
| 40 g whole ground flaxseed175 g yogurt with 40 g whole ground flaxseed | Dietary supplement | 40 g whole ground flaxseed |
| 40 g roasted then ground whole flaxseed175 g yogurt with 40 g roasted then ground whole flaxseed | Dietary supplement | 40 g roasted then ground whole flaxseed |
| 40 g of whole intact flaxseeds175 g yogurt with 40 g of whole intact flaxseeds | Dietary supplement | 40 g of whole intact flaxseeds |
| 28 g flax hulls175 g yogurt with 28 g flax hulls | Dietary supplement | 28 g flax hulls |
Primary outcome
Peak blood level of cyanide
Time frame: 180 minutes
highest concentration of cyanide during 180 min postprandial period
iAUC blood cyanide
Time frame: 180 min
incremental area under the curve for cyanide from 0-180 min
1 secondary outcome
Cyanogenic glycoside and thiocyanate concentrations in plasma and urine
Time frame: 180 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 25708890Abraham 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.
- BackgroundAgbor-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: PubMed 10418947Carlsson 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.
- Background: PubMed 30615957Cressey 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.
- BackgroundCressey 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: PubMed 37586035Diaz-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.
- Background: PubMed 32626287EFSA 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.
- Background: PubMed 24579992Gleadow 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.
- BackgroundJoint FAO/WHO Expert Committee on Food Additives (JECFA). Safety evaluation of certain food additives and contaminants. WHO food additives series; 65. 2012
- BackgroundMazza 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: PubMed 10995312Muir 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.
- Background: PubMed 12842188Ngudi 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.
- New Zealand Food Safety Authority. Cyanogenic glycosides -Information sheet.Link provided by the sponsor.
- 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-S170Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Blewett, PhD principal investigator
Agriculture and Agri-Food Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0 g Flax, 40 g whole ground flaxseed and 40 g roasted then ground whole flaxseed in people with Healthy, run by St. Boniface Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Blewett, PhD (204-237-2954, hblewett@sbrc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak blood level of cyanide (time frame: 180 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06491095, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.