Healthy
Conditions
Keywords
Flax, Blood Cyanide
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.
Detailed description
Participants will receive yogurt containing the following flaxseed products in a random order: 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.
Interventions
DIETARY_SUPPLEMENT0 g Flax
175 g yogurt with no flax product
DIETARY_SUPPLEMENT40 g whole ground flaxseed
175 g yogurt with 40 g whole ground flaxseed
DIETARY_SUPPLEMENT40 g roasted then ground whole flaxseed
175 g yogurt with 40 g roasted then ground whole flaxseed
DIETARY_SUPPLEMENT40 g of whole intact flaxseeds
175 g yogurt with 40 g of whole intact flaxseeds
DIETARY_SUPPLEMENT28 g flax hulls
175 g yogurt with 28 g flax hulls
Sponsors
Agriculture and Agri-Food Canada
St. Boniface Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Generally healthy adult, 18 years or older; 2. Willing to provide informed consent; 3. Willing/able to comply with the requirements of the study.
Exclusion criteria
1. Pregnant or lactating; 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak blood level of cyanide | 180 minutes | highest concentration of cyanide during 180 min postprandial period |
| iAUC blood cyanide | 180 min | incremental area under the curve for cyanide from 0-180 min |
Secondary
| Measure | Time frame |
|---|---|
| Cyanogenic glycoside and thiocyanate concentrations in plasma and urine | 180 minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concentration of metabolites in blood and urine | 180 minutes | Identification and concentration of metabolites in plasma and urine determined by LC-QTOF-MS |
Countries
Canada
Contacts
Primary ContactHeather Blewett, PhD
Outcome results
None listed