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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT02226250
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age and older
* Body Mass Index (BMI) range from 25 to 29.9 kg/m2; exception BMI 23 to 27.4 kg/m2 for Asian population
* Nonsmoker
* No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
* Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements.
* Able to provide informed consent
* Able to comply and perform the procedures requested by the protocol Weight stable: not gained or lost weight +/- 5 kg in previous 3 months
Exclusion Criteria:
* Men and women who smoke
* Past smokers: abstinence for minimum 2 years
* Men and women with known or suspected food intolerance, allergies or hypersensitivity
* Men and women known to have/diagnosed with diabetes mellitus
* Men and women who have fasting blood glucose concentrations \> 125mg/dL
* Men and women who have blood pressure \>140 mmHg/90 mmHg
* 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.
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study
* Women who are lactating
* Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, 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.
* Men and women who are vegans
* Substance (alcohol or drug) abuse within the last 2 years.
* Excessive coffee and tea consumers (\> 4 cups/d)
* Men and women who do excessive exercise regularly or athlete
* Unstable weight: gained or lost weight +/- 5 kg in previous 3 months
* Women who are taking hormonal contraceptive
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02226250
Study Brief:
Protocol Section:
NCT02226250