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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT05399134
Eligibility Criteria:
Inclusion Criteria:
* Chinese ethnicity
* English-speaking
* Age between 21 - 70 years old inclusive.
* Confirmed Type 2 Diabetes with HbA1c level of less than 10%
* Not on prandial insulin therapy
* Subjects with stable medical problems not limited to hypertension and hyperlipidemia
Exclusion Criteria:
* Current smoker or use of tobacco products within the 3 months
* Vegetarian or other dietary restrictions that would not allow the subject to consume the test meal.
* Persons with electronic medical implants (e.g. pacemaker).
* Persons with known or ongoing psychiatric disorders or drug abuse within 3 years.
* Women who are pregnant or lactating.
* Persons with an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females). 1 unit is equivalent to:
* 12 oz or 360 mL of beer;
* 5 oz or 150 mL of wine;
* 1.5 oz or 45 mL of distilled spirits.
* Persons with active infection(s) requiring systemic, antiviral or antimicrobial therapy that will not be completed prior to the first study visit
* Persons who have undergone treatment with any investigational drug or biological agent within one (1) month of screening or plans to enroll in another study involving investigational drugs/biological agents during the duration of this study.
* Persons with significant change in weight (+/- 5%) during the past month.
* Persons with a known allergy to rice bran, dietary fiber, alginate and other study components (anthocyanins, soy protein).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT05399134
Study Brief:
Protocol Section:
NCT05399134