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 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT03679195
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged between 18-75 years
* For women with child-bearing potential, acceptable effective contraceptive methods are: total abstinence, hormonal birth control methods (oral, injectable, transdermal or intra-vaginal), intrauterine devices, confirmed successful vasectomy of partner
* Stable weight for at least three 3 months (±5lbs)
* Mean daytime SBP between 125 and 134.9 mmHg and DBP \< 85 mmHg
* Otherwise healthy individuals
Exclusion Criteria:
* Women during a peri-menopausal period
* Pregnant/breastfeeding women
* Mean daytime SBP \<125 or \>134.9 mmHg or DBP ≥85 mmHg
* History of cardiovascular disease, type 2 diabetes, monogenic dyslipidemia or endocrine disorders
* Use of anticoagulants or thrombocyte aggregation inhibitors, chemotherapeutic agents, anti-inflammatory drugs, medication for blood lipids, diabetes, hypertension, erectile dysfunction or auto-immune diseases
* Any clinical signs or laboratory evidence for inflammatory, gastrointestinal, endocrine, renal, pulmonary, neurological, cardiovascular, metabolic, haematological problem or cancer
* Kidney stones
* Excess alcohol consumption (\> 14 consumptions/week) or drug consumption
* Hypersensitivity/allergy to one of the ingredients (including non-medicinal ingredients) in NO Ultra supplement/placebo
* Use of additional cranberry/grape seed extract or citrulline products
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03679195
Study Brief:
Protocol Section:
NCT03679195