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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT02481466
Eligibility Criteria:
A) Inclusion Criteria:
* Eligible participants will be
* men over 21 years
* post-menopausal women
Having a BMI less than or equal to 40 kg/m2 and who have measurable arterial thickening (\>/=1.2mm) at screening as assessed by ultrasound.
They will include those who have at least 1 of the following characteristics:
1. Type 2 diabetes
2. Non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy;
3. Hyper-cholesterolemic and treated with statins or have been prescribed statins but are not taking it because they are either unable (intolerant) or unwilling to take statin drugs.
4. Raised blood pressure, \>140/90 (untreated)
B) Exclusion Criteria:
* Individuals with the following conditions will be excluded:
* cardiovascular disease that precludes exercise e.g.
* recent stroke or
* recent myocardial infarction or
* cardiac condition that severely compromises normal function:
* mitral valve disease, atrial fibrillation and individuals with Implantable Cardioverter Defibrillator (ICD)
* heart failure--grades 2-4 (based on New York Heart Association classification),
* severe angina sufficient to prevent any form of physical activity
* other conditions preventing exercise.
* secondary causes of hypercholesterolemia e.g. hypothyroidism (unless treated and on a stable dose of L-thyroxin), clinically significant renal (that precludes dietary change) or liver disease .
* LDL-cholesterol \<1.4mmol/L
* uncontrolled blood pressure
* major disability
* disorder requiring continuous medical attention (on Coumadin) and treatment, such as:
* chronic heart failure
* liver disease
* renal failure or
* cancer (except non-melanoma skin cancer--basal cell, squamous cell)
* chronic infections (bacterial or viral)
* chronic inflammatory diseases (eg. lupus, ulcerative colitis, crohn's disease, celiac disease or gluten sensitivity)
* other autoimmune disease
* major surgery \<6 months prior to randomization
* newly diagnosed with diabetes (\<3 months)
* alcohol consumption \>3 drinks/d
* not suitable for MRI examination because of metal implants or claustrophobia
* food allergies or sensitivity to study foods or study food components (eg. tree nuts, peanuts, soy, wheat, gluten, oats, eggs, milk)
* already following a portfolio-like diet (and are not prepared to change) or have a structured exercise program which they cannot increase any further
* do not have a family doctor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02481466
Study Brief:
Protocol Section:
NCT02481466