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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT06546020
Eligibility Criteria:
Inclusion Criteria for Metabolically Healthy Group:
All of the following:
* Waist circumference: men ≤ 40, women ≤ 35 inches
* Systolic blood pressure: ≤ 130 mmHg
* Diastolic blood pressure: ≤ 85 mmHg
* Fasting glucose: ≤ 100 mg·dl-1
* Fasting triglycerides: ≤ 150 mg·dl-1
* HDL: men \> 40, women \> 50 mg·dl-1
Inclusion Criteria for Metabolically Unhealthy Group:
Required:
\- Waist circumference: men ≥ 40, women ≥ 35 inches
AND ≥ 1 of the following:
* Systolic blood pressure: \> 130 mmHg
* Diastolic blood pressure: \> 85 mmHg
* Fasting glucose: \> 100 mg·dl-1
* Fasting triglycerides: \> 150 mg·dl-1
* HDL: men ≤ 40, women ≤ 50 mg·dl-1
Exclusion Criteria:
* BMI \<18 or \> 40 kg/m\^2
* potential allergy to Haskap or placebo ingredients
* use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or any other medications that may interfere with study measures
* pregnant or lactating woman
* diagnosis with type 1 or type 2 diabetes or any other condition that may interfere with study measures
* smoke cigarettes
* have taken antibiotics in the past 90 days
* take supplements including pre/probiotics or "superfoods" within 30 days of starting the study
* are planning on starting a weight loss or exercise regiment change
* follow a specific diet such as low carbohydrate, vegan, and vegetarian
* consume over 5 servings of fruit/vegetables per day
* are unwilling to reduce caffeine intake to one 8 oz serving per day for the durations of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT06546020
Study Brief:
Protocol Section:
NCT06546020