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:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT04595006
Eligibility Criteria:
Inclusion Criteria:
* Male or Female
* Chinese, Malay or Indian ethnicity
* Age between 21 to 50 years
* Able to give informed consent
* Body mass index (BMI) between 23 to 32 kg/m2
* Thyroid function test must be within the normal ranges
* Willing to avail yourself for the whole study and follow study procedures
* EITHER deemed to have pre-metabolic syndrome when waist circumference is \> 90 cm in men or \> 80 cm in women, with none or up to one of the following condition:
* Triglyceride level ≥ 1.7 mmol/L
* HDL cholesterol ≤ 1.0 mmol/L in men, and ≤ 1.3 mmol/L in women
* Blood pressure ≥ 130/85 mmHg
* Fasting blood glucose of ≥ 6.1 mmol/L
* OR deemed to have metabolic syndrome when three or more of the following conditions are present:
* Waist circumference \> 90 cm in men and \> 80 cm in women
* Triglyceride level ≥ 1.7 mmol/L
* HDL cholesterol ≤ 1.0 mmol/L in men, and ≤ 1.3 mmol/L in women
* Blood pressure ≥ 130/85 mmHg
* Fasting blood glucose of ≥ 6.1 mmol/L
Exclusion Criteria:
* Are pregnant or contemplating pregnancy (for female subjects)
* Partake in sports at the competitive and/or endurance levels
* Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Have major chronic disease such as heart disease or cancer
* Take insulin or drugs known to affect glucose metabolism
* Intentionally restrict food intake
* Have major medical or surgical event requiring hospitalization within the preceding 3 months
* Have taken antibiotics for 3 months before the study period
* Are a smoker
* Are an overnight shift worker
* Have any known food allergy (eg. anaphylaxis to peanuts)
* Having active Tuberculosis (TB) or currently receiving treatment for TB
* 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)
* Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC
* Have poor veins impeding venous access
* Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
* History of surgery with metallic clips, staples or stents
* Presence of cardiac pacemaker or other foreign body in any part of the body
* History of claustrophobia particularly in a MRI scanner
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT04595006
Study Brief:
Protocol Section:
NCT04595006