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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT06640335
Eligibility Criteria:
Inclusion Criteria:
* Normal body mass index (18.5 kg/m2 to 24.9 kg/m2), weight \>/= 45 kg
* Normal blood pressure \</=120/80 mmH
* Fasting blood glucose of \<5.6 mmol/l
* Able to provide written informed consent before participating in the study.
* Able to communicate adequately to comply with the requirements of the entire study, i.e., able to eat test meal and provide breath samples.
Exclusion Criteria:
* Smokers.
* Individuals with any metabolic diseases (such as diabetes, hypertension etc).
* Individuals with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency).
* Individuals with medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics).
* Individuals who take any prescribed medication or dietary supplements which may interfere with the study measurements.
* Individuals who have any major organ dysfunction (eg. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug.
* Individuals with history of malabsorption due to mucosal disease, pancreatic disease, or other causes.
* Individuals with history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders).
* Individuals who are allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, sulphites etc.
* People who intentionally restrict food intake.
* People who consume excessive 13C rich products such as corn, sugar beet and pineapple.
* Individuals who partake in sports at the competitive and/or endurance levels
* Individuals who have any known chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV).
* Individuals who is a study team member or an immediate family of any study team member.
* Individuals who consume Excessive alcohol: consuming \>/= 6 alcoholic drinks per week.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT06640335
Study Brief:
Protocol Section:
NCT06640335