Clinical trial NCT06491095: Effect of Flax in Yogurt on Blood Cyanide Levels
Official title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Flaxseed on Blood Cyanide Levels in Healthy Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Flax
Blood Cyanide
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2024-07-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak blood level of cyanide
timeFrame: 180 minutes
measure: iAUC blood cyanide
timeFrame: 180 min
Secondary outcomes:
measure: Cyanogenic glycoside and thiocyanate concentrations in plasma and urine
timeFrame: 180 minutes
Other outcomes:
measure: Concentration of metabolites in blood and urine
timeFrame: 180 minutes
Locations:
city: Winnipeg
country: Canada
facility: I. H. Asper Clinical Research Institute
state: Manitoba
Study officials:
affiliation: Agriculture and Agri-Food Canada
name: Heather Blewett, PhD
role: PRINCIPAL_INVESTIGATOR
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