NCT06502535Completed
Inulin and Nitrate's Effects on Vascular Health and Gut Microbiome
The Effects of Inulin and Inorganic Nitrate on Flow-Mediated Dilation and Gut Microbiome in Adults with Pre-Hypertension and Hypertension
Source: ClinicalTrials.gov · Last updated 9 Jan 2025
Brief summary (registry, in English)
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 to decreased nitric oxide production. Flow-mediated dilation (FMD) is a widely used technique for assessing vasodilation, which gauges the capacity of blood vessels to widen in response to increased blood flow. Nitrate supplements have been shown to enhance blood vessel function both in the short and long term by elevating nitric oxide (NO) production. Similarly, acetate, a by-product of fibre digestion, has demonstrated anti-inflammatory effects in the gut and may also increase NO production. However, further investigation is needed to determine whether these two supplements work synergistically to improve FMD responses by augmenting NO production in the human body. This study will involve administering inulin plus nitrate supplements to adults aged 45-74 with untreated high blood pressure (120-139/80-89 mmHg and 140/90 mmHg or higher) for a period of 4 weeks, followed by a subsequent 4-week period where only inulin supplements are consumed. The supplements will be provided in the form of powder, to be mixed with water, and will be given in a cross-over and counterbalanced order. Various measurements, including brachial artery function, faecal samples, blood pressure, plasma nitrate and nitrite levels, plasma short-chain fatty acid levels, red blood cell and whole blood S-Nitrosothiols, and salivary nitrate and nitrite levels, will be taken at the baseline and after each supplementation period. Additionally, acute supplementation measurements will be collected on two separate occasions before the start of the longer-term supplement regimen.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 14 May 2024
- Start date
- 9 May 2023
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- University of Exeter
- Diseases
- High blood pressure
- NCT number
- NCT06502535
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 9 May 2023 to the primary completion date, 31 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
- Allergies or intolerance against the substances used in the study and/or food intolerances associated with gastrointestinal upset;
Lab values
- 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.
Other
- Body mass index \> 40 kg/m\^2 at screening;
- 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;
- Self-reported use of antimicrobial mouthwash or tongue scrapes, unless discontinued during the trial.
Who the study is looking for
- 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)
Age in the registry: 45 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Exeter Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.