Hypertension Circulatory System Hypertension (high blood pressure)
Conditions
Interventions
The study is divided in four phases: selection of participants, screening, baseline/randomisation and intervention.
Participants will be randomised into 3 groups using an online platfo
Sponsors
Institute of Cellular Medicine, Newcastle University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 50-70 years old 2. Non-smokers 3. Drug naïve 4. Hypertension (stage 1, systolic blood pressure 130-170 mmHg) 5. BMI 18-40 kg/m²
Exclusion criteria
Exclusion criteria: 1. Current participation in other clinical investigations 2. Physical disabilities, trauma or surgery which limit mobility and affect participation to the trial 3. Vegetarianism 4. Aversion to beetroot consumption or inability to comply with the study diet 5. Substantial weight change in the last 3 months 6. Active cancer and any diagnosis of malignant cancer in the last 5 years 7. Chronic and acute metabolic and inflammatory conditions interfering with the study outcome (e.g. history of severe liver disease, inflammatory bowel diseases or rheumatoid arthritis) 8. Previous diagnosis of type 1 or type 2 diabetes treated with insulin 9. Taking any drugs that have an effect on nitric oxide production or insulin sensitivity, including oral corticosteroids, sildenafil, anti-hypertensive (beta-blockers, calcium antagonists, ace-inhibitors and angiotensin receptors inhibitors), diuretics, laxatives, anticoagulants, nitrate derived agents and anti-cholinergics 10. Taking hormonal therapies (oestrogens, thyroxine, progesterone, oral hypoglycaemic agents) if the dose has been started/changed in the previous 3 months 11. Taking statins and any other anti-dyslipidaemic agent if the dose has been started/changed in the previous 3 months 12. Taking psychiatric drugs (antidepressants, sedatives, antipsychotics) if the dose has been started/changed in the previous 3 months 13. History of severe anaemia (Hb < 8mg/dL) (risk for the participant and effects on the study outcomes). 14. Current diagnosis of severe infectious diseases (known HIV positive, malaria, hepatitis, yellow fever etc) 15. Major surgical operations interfering with the study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance to the intervention, assessed using self-developed standardised feedback questionnaires at the baseline, 30 days and 60 days (end of the study). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in resting and 24 hour ambulatory blood pressure (BP): 1.1. Resting blood pressure assessed using an automated BP monitor at the baseline, after 1 month and at the end of the study 1.2. 24 hour ambulatory blood pressure assessed using a BP monitor with an inflatable cuff secured around the arm, which will regularly inflate and deflate over the 24 hour period 2. Changes in whole-body nitric oxide (NO) production, assessed using the Oral Nitrate Test (non-invasive stable isotope method) at the baseline and after 60 days (end of the study) 3. Blood nitrate concentration, assessed using the ONT method, with samples then being derivatised using the nitromesitylene method and the enrichment level of the tracer will be determined using gas chromatography/mass spectrometry at the baseline and after 60 days (end of the study) 4. Blood folate concentration, assessed using the ONT method, with samples then being derivatised using the nitromesitylene method and the enrichment level of the tracer will be determined using gas chromatography/mass spectrometry at the baseline and after 60 days (end of the study) 5. Validity of Berkeley Life Nitric Oxide Saliva Test Strips for the assessment of nitrite concentrations, assessed at the baseline and after 30 and 60 days | — |
Countries
England, Tanzania, United Kingdom
Outcome results
None listed