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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT04930250
Eligibility Criteria:
Inclusion Criteria:
1. Male and female participants, age between 24 and 39 years
2. Healthy individuals with no comorbidities or on regular medication
3. BMI between 18.5-25 kg/m2
4. Able to understand and willing to sign an informed consent form in English
5. Regularly consume breakfast
6. Able and willing to consume 330ml of liquid in 10 minutes
7. For female participants, have a regular menstrual cycle
Exclusion Criteria:
1. Known food allergies or intolerances specifically to gluten, milk, lactose or any grains
2. Known drug allergies specifically paracetamol
3. Known sensitivity or has had an adverse reaction to paracetamol and non-steroidal anti-inflammatory drugs (NSAID) in the past
4. Individuals with regular prescriptions or regularly consume medication (at least once a month), including alternative medicine (e.g. traditional Chinese medicine)
5. Had been diagnosed or with a history of any metabolic disease or disorders, including diabetes, gestational diabetes and hypertension
6. Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
7. Had been hospitalised in the 3 months prior to the study.
8. Pregnant or lactating women, or planning to conceive in the next 3 months
9. Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit.
10. Smokers
11. Poor peripheral venous access based on past experiences with blood draw
12. Significant change in weight (≥ 3 kg body weight) in the past 3 months
13. Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
14. Currently on a specialised diet e.g. vegetarian, vegan, weight loss plan, high protein diet
15. Unwilling to refrain from consuming fibre or prebiotic supplements, high fibre ingredients and more than 5 servings of fruits and vegetables per day over the length of the study.
16. Has donated blood in the past one month
17. Hierarchical link with the research team members
18. Participating in another clinical study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Years
Maximum Age:
39 Years
Study:
NCT04930250
Study Brief:
Protocol Section:
NCT04930250