Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT06491095
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06491095
Study Brief:
Protocol Section:
NCT06491095