Effects of beetroot juice and folate supplementation on blood pressure

Not Applicable

Completed

• Conditions: Hypertension; Circulatory System; Hypertension (high blood pressure)

• Registration Number: ISRCTN67978523
• Lead Sponsor: Institute of Cellular Medicine, Newcastle University

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32729923/ results (added 03/08/2020) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31872153/ Design and baseline characteristics (added 17/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-07
• Study Start: 2018-11-05
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance to the intervention, assessed using self-developed standardised feedback questionnaires at the baseline, 30 days and 60 days (end of the study).