Status:
COMPLETED
Inulin and Nitrate's Effects on Vascular Health and Gut Microbiome
Lead Sponsor:
University of Exeter
Collaborating Sponsors:
University of East Anglia
Conditions:
Endothelial Dysfunction
High Blood Pressure
Eligibility:
All Genders
45-74 years
Phase:
NA
Brief Summary
Previous research has revealed that adults with pre-hypertensive and hypertensive blood pressure levels typically exhibit impaired vasodilation, which is a crucial aspect of blood vessel function, due...
Detailed Description
Endothelial dysfunction contributes to the increased cardiovascular risk associated with high blood pressure levels (e.g., 120-139/80-89 mmHg and 140/90 mmHg or higher), and it is considered as an ear...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06502535
Start Date
May 9 2023
End Date
July 31 2024
Last Update
January 9 2025
Active Locations (1)
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1
University of Exeter
Exeter, Devon, United Kingdom, EX2 4TH