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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT06092632
Eligibility Criteria:
Inclusion Criteria:
* Aged 20-59 years.
* Body mass index between 18.5 -35 kg/m2
* Elevated cholesterol (total cholesterol \>200 mg/dL or LDL cholesterol 130-190 mg/dL), and/or impaired fasting glucose (100-125mg/dL)
* Eat rice as a staple food at least twice per day
Exclusion Criteria:
* Are pregnant or lactating
* Regularly consume pigmented rice (two meals per day in the past 4 weeks)
* Have cardiovascular disease (hypertension, stroke, ischemic heart disease, myocardial infarction, or congestive heart failure) or diabetes mellitus
* Take cholesterol or glucose-lowering medications
* Have elevated blood pressure (\>130/80 mmHg)
* Have an illness that may influence lipid metabolism or metabolic rate (liver cirrhosis, pancreatitis, chronic kidney disease, hyperthyroidism, hypothyroidism)
* Take supplements that may influence lipids and glucose levels (including polyphenols)
* Are on a strict diet regimen (calorie-restricted or excluding food groups, examples: (Examples: Ketogenic diet, Intermittent fasting, No Rice diet)
* Have an active lifestyle (Ex. Goes to the gym daily, regularly (≥3 times a week) and perform vigorous activities such as lifting weights, swimming, cycling fast or uphill, or running, or athlete)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
59 Years
Study:
NCT06092632
Study Brief:
Protocol Section:
NCT06092632