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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06502535
Eligibility Criteria:
Inclusion Criteria:
* Able to provide informed consent
* Adults aged 45-74
* Adults with untreated elevated blood pressure as SBP 120 to 129 mm Hg and DBP \< 80 mm Hg or untreated stage 1 hypertension (i.e., pre-hypertension) as SBP 130 to 139 mm Hg or DBP 80 to 89 mm Hg or untreated stage 2 hypertension as SBP equal to or higher than 140 mm Hg or DBP equal to or higher than 90 mm Hg (ACC/AHA and ESC/ESH guidelines and Blood Pressure UK)
* Weight-stable in the 3 months prior to enrolment (self-report)
Exclusion Criteria:
* Body mass index \> 40 kg/m\^2 at screening;
* History of symptomatic coronary artery disease, stroke, or other known atherosclerotic disease;
* History of gastrointestinal disease (e.g., irritable bowel syndrome, inflammatory bowel disease, coeliac disease, Chron's disease) or former abdominal surgery, weight loss surgery e.g., gastric by-pass (except for appendectomy);
* History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders;
* History of malignancy within the past 5 years, other than non-melanoma skin cancer;
* History of diabetes and/or any endocrine disorder;
* Current use of nitrate medications, including glyceryl trinitrate (GTN), isosorbide dinitrate and isosorbide mononitrate and blood pressure medications;
* Consumption of a low calorie or other special diet during the last month prior to the study, or if following a slimming or medically prescribed diet, or a vegan or macrobiotic lifestyle;
* Use of antibiotics during the three months prior to screening;
* Consumption of pre- or probiotics during the last month prior to screening and during the study, unless discontinued 3 weeks before the start of the trial. This is referred to the use of supplements only and NOT foods containing probiotics and/or prebiotics foods;
* Consumption of dietary supplements such as vitamins C and E during the last month prior to the screening and during the trial, unless discontinued 3 weeks before the start of the trial;
* Consumption of fish oil 6 weeks prior to the screening and during the trial, unless discontinued 6 weeks before the start of the trial;
* Allergies or intolerance against the substances used in the study and/or food intolerances associated with gastrointestinal upset;
* Any apparent dependence on or abuse of alcohol, tobacco, and cannabis products;
* Pregnancy, breast-feeding, or plans to become pregnant during the duration of the study;
* Current use of nitrate supplements in the form of beetroot juice, beetroot crystals, potassium nitrate and sodium nitrate, including L-arginine or L-citrulline supplements.
* Self-reported use of antimicrobial mouthwash or tongue scrapes, unless discontinued during the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
74 Years
Study:
NCT06502535
Study Brief:
Protocol Section:
NCT06502535