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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT02695433
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 25-65 yrs.
* BMI of 25 - 42 kg/m2
* HOMA-IR ≥ 2
* Abdominal obesity: mid-point waist circumference \>102 cm for men and \>88 cm for women
* No clinical evidence / history of heart disease, respiratory, renal, gastrointestinal, or hepatic disease
* Not taking over-the-counter or prescription medications/dietary supplements that may interfere with study procedures or endpoints (e.g., antioxidant supplements, protein powder, energy drinks, anti-inflammatory or lipid-lowering medications).
* Non-smoker or past smoker (smoking cessation \> 2 yrs.)
* Able to provide informed consent and comply with study procedures
Exclusion Criteria:
* Aged \< 25 or \> 65 years
* BMI \< 25 kg/m2 or \> 42 kg/m2
* HOMA-IR \< 2.0
* History of heart disease, respiratory, renal, gastrointestinal or hepatic disease
* Diabetes
* Have or had cancer other than non-melanoma skin cancer in past 5 years
* Taking over-the-counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints (including protein powers, energy drinks)
* Vegan dietary habits, unusual dietary habits or sensitive or allergic to any of the test meal components / ingredients
* Consuming 3 or more avocados per week.
* Consuming 3 or more servings of nuts or peanuts per week, unless subject is willing to stop consuming nuts 4 weeks before and throughout the course of the study.
* Excessive coffee and tea consumers (\>4 cups/day)
* Current smoker
* Actively losing weight or trying to lose weight (unstable body weight fluctuations of \> 5 kg in 3 months
* Drug or alcohol addiction
* Present with significant psychiatric or neurological disturbances
* Working overnight (e.g 3rd shift of overnight workers)
* Pregnant, lactating or planning to become pregnant
* 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.
* Women who are taking unstable dose and brand of hormonal contraceptive and/or stable dose and brand less than 6 months
* Excessive exercisers or trained athletes
* Take part in chronic feeding or medication clinical trial in the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT02695433
Study Brief:
Protocol Section:
NCT02695433