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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT03506932
Eligibility Criteria:
Inclusion Criteria:
1. Generally healthy male or female, between the age of 18-40 years;
2. Body mass index (BMI) 18.5-30.0 kg/m2;
3. Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively;
4. Willing to provide informed consent;
5. Willing/able to comply with the requirements of the study.
Exclusion Criteria:
1. Pregnant or lactating;
2. Medical history of diabetes mellitus, fasting blood glucose ≥6.1 mmol/L, HbA1c ≥6.0%, or use of insulin or oral medication to control blood sugar;
3. Medical history of cardiovascular disease;
4. Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg;
5. Fasting plasma total cholesterol \>7.8 mmol/L;
6. Fasting plasma HDL \<0.9 mmol/L;
7. Fasting plasma LDL \>5.0 mmol/L;
8. Fasting plasma triglycerides \>2.3 mmol/L;
9. Major surgery within the last 3 months;
10. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
11. Medical history of liver disease or liver dysfunction (defined as plasma aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN));
12. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥3 times the ULN));
13. 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;
14. Active treatment for any type of cancer within 1 year prior to study start;
15. Shift worker (a system of employment where an individual's normal hours of work are in part, outside the period of normal working day; 6am and 8pm);
16. Smoking, use of tobacco or a nicotine replacement product, and cannabis in any form (within the last 3 months);
17. Allergies to peas or wheat;
18. Aversion or unwillingness to eat study foods;
19. Consuming \>4 servings of pulses per week;
20. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycaemia or appetite;
21. Participation in another clinical trial, current or in the past 4 weeks;
22. Unstable body weight (defined as \>5% change in 3 months) or actively participating in a weight loss program.
23. Other medical, psychiatric, or behavioral factors that in the judgment of the principal Investigator may interfere with study participation or the ability to follow the intervention protocol;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03506932
Study Brief:
Protocol Section:
NCT03506932