Status:
NOT_YET_RECRUITING
Effect of Flax in Yogurt on Blood Cyanide Levels
Lead Sponsor:
St. Boniface Hospital
Collaborating Sponsors:
Agriculture and Agri-Food Canada
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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 whol...
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 who...
Eligibility Criteria
Inclusion
- Generally healthy adult, 18 years or older;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study.
Exclusion
- 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);
- Allergies to flaxseed or yogurt;
- Aversion or unwillingness to eat study foods;
- Participation in another clinical trial, current or in the past 4 weeks
Key Trial Info
Start Date :
January 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 28 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06491095
Start Date
January 16 2025
End Date
March 28 2026
Last Update
December 2 2024
Active Locations (1)
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1
I. H. Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H 2A6