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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02881658
Eligibility Criteria:
Inclusion Criteria:
* Southern Chinese male or female ≥ 18 years;
* In good general health as evidenced by medical history;
* Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclose of research-related health information, and comply with the study data collection procedures. Provide signed and dated informed consent form
Exclusion Criteria:
* Subject with familial hypercholesterolemia;
* On regular medication(s) which affect gastrointestinal functions and blood lipids level for the past 3 months, such as, but not limited to:
* Antibiotics of \>1 week duration
* GI related medications such as antacids
* Having blood lipid lowering medications such as statins, selective cholesterol absorption inhibitors (e.g. ezetimibe), fibrates, niacin, resins, omega- 3
* Heavy-smokers (more than 1 pack per day)
* Subject with heavy alcohol intake (\>40 g/day for men ; \>30 g/day for women) (32), or having history of alcohol abuse within 12 months prior to the study
* Subjects with taste aversion to placebo/intervention soya beverages
* Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product) or having regular consumption of sterols/stanols cholesterol-lowering supplements/functional foods or other related products such as:
* Sterol/ Stanol - containing margarines, milk, yoghurt drink and soya beverages
* Sterol / Stanol supplements
* Fish oils \& omega-3 supplements
* Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
* Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial
* Pregnancy or lactation
* Having soy allergy
* Being a vegan
* Being an athlete
* Concurrently participating in weight management or dietary program
* On diet pills, such as, but not limited to chitosan and dulcolax
* With history of sitosterolemia
* Having history of hypercholesterolemia, diabetes, thyroid disease, severe kidney diseases, cardiovascular diseases, chronic gastrointestinal disorders, cancers and AIDs ( acquired immune deficiency syndrome)
* Having history of malabsorption syndrome arising from diseases such as, but not limited to celiac disease, short bowel syndrome, cystic fibrosis, pancreatitis, diseases of gall-bladder, liver or pancreas, intestinal infection, injury, surgery and radiotherapy
* Taking over-the-counter Chinese medications or supplements with cholesterol/lipid lowering and related claims
* High blood cholesterol at screening \[Total cholesterol level ≥6.22mmol/L\]
* High LDL cholesterol \[LDL cholesterol level ≥4.15mmol/L\]
* High blood triglyceride at screening \[Triglyceride ≥3.39mmol/L\]
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02881658
Study Brief:
Protocol Section:
NCT02881658