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:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT04745702
Eligibility Criteria:
Inclusion Criteria:
* Chinese Male or Female• Age between 45-75 years
* Body mass index 19.5-32.0 kg/m2
* Deemed to be prediabetic based on meeting any 1 of 3 following criteria:1. Fasting blood glucose \>5.5 mmol/l and \<7.0 mmol/l2. Oral glucose tolerance test (OGTT) level \>/=7.8 mmol/l and \</=11.0 mmol/l3. Haemoglobin A1c (HbA1c) level \>/=5.7 and \</=6.4%.
Exclusion criteria:
* Smoking
* Having allergies or intolerances to any common food ingredients including eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
* Following special diets or having intentional dietary restrictions (e.g, vegetarians/vegans)
* Not willing to adhere to diet modification as in the study protocol
* Not willing to stop any strenuous activity during or within 24 hours of test days (for those actively participating in sports at the competitive and/or endurance levels)
* Having glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* Having alcohol consumption on \> 4 days per week with ≥ 6 alcoholic drinks per week
* Having sustained elevation of blood pressure (\>160/95 mm Hg)
* Having previously undergone any gastrointestinal surgery or having history of gastrointestinal disorders
* Having a history of heart, liver, kidney, blood disorders (e.g., thalassemia) or thyroid dysfunctions
* Diabetic
* Having history of tuberculosis, HIV, Hepatitis B or Hepatitis C infections
* Having any prescription medication or any other alternative medicines or supplements which may interfere with study measurements in the in the opinion of the study investigators
* Having antibiotics or suffering from diarrhea within the last 3 months
* Having donated blood within 4 weeks of study participation
* Having poor veins or having history of severe vasovagal syncope (blackouts or fainting) from blood draws
* Having more than 5% weight loss or gain over the past 3 months
* For female volunteers: menstruation within past 12 months or being on hormone replacement therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT04745702
Study Brief:
Protocol Section:
NCT04745702