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 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT02035592
Eligibility Criteria:
Inclusion Criteria:
* Men and postmenopausal women (≥ 1 year since last menstruation)
* 50 to 75 years old
* BMI of ≥ 25 kg/m2
* 3 characteristics of metabolic syndrome i.e: Waist circumference ≥ 102 cm for men, ≥ 88 cm for women; Triglycerides ≥ 1.7 mmol/L (or drug treatment for elevated triglycerides); HDL-cholesterol \< 1.0 mmol/L for men, \< 1.3 mmol/L for women (or drug treatment for low HDL-cholesterol); Blood pressure ≥ 130 mm Hg systolic and/or ≥ 85 mm Hg diastolic blood pressure; Fasting blood glucose ≥ 5.56 mmol/L
* Successful biochemical, haematological and urinalysis assessment at screening
Exclusion Criteria:
* Current smokers, or ex-smokers ceasing \< 6 months ago
* Existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures
* Fructose intolerance or known allergies to the intervention treatments
* On therapeutic diets or having experienced substantial weight loss within 3 months of screening
* Taking flavonoid containing supplements (and unwilling to cease intake during, and 1 month preceding the trial)
* Planning on altering consumption of vitamin supplements / fish oil capsules during the course of the study.
* Prescribed hypoglycaemic, vasodilators or HRT medication.
* Unsatisfactory biochemical, haematological or urinary assessment at screening, or measures considered to be counter indicative for the study
* \< 3 characteristics of the metabolic syndrome.
NB: REC approved NoSA granted to include those on anti-hypertensives (29JUL2014)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
74 Years
Study:
NCT02035592
Study Brief:
Protocol Section:
NCT02035592