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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT02479035
Eligibility Criteria:
Inclusion Criteria:
* Fasting blood sugar between 100-125 mg/dL and fasting insulin concentration ≥ 8 uIU/mL for Prediabetes,insulin-resistant group
* Fasting blood sugar \< 100 mg/dL and the homeostasis model assessment method of insulin resistance (HOMA-IR) (glucose \[in millimoles per liter\] × insulin \[in microunits per milliliter\]/22.5) values less than 1 for reference/control group.
* Aged between 20 to 60 years old male/female
* Non-smoker or Past smokers: abstinence for less than 2 years
* No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
* Not taking any medications or dietary supplements that would interfere with outcomes of the study.
Exclusion Criteria:
* Men and women who smoke
* Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
* Men and women known to have/diagnosed with diabetes mellitus
* Men and women who have fasting blood glucose concentrations ≥126 mg/dL
* Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
* Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
* interfere with the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
* Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
* Substance (alcohol or drug) abuse within the last 2 years.
* Excessive coffee and tea consumers (\> 4 cups/day)
* Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study and women who are lactating
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT02479035
Study Brief:
Protocol Section:
NCT02479035