Investigation of the effects of beetroot juice supplementation on blood pressure in older overweight and obese subjects

Completed

• Conditions: Blood Pressure, Hypertension, Cardiovascular Disease, Nutrition, Vascular Health; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN85926713
• Lead Sponsor: ewcastle University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-28
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Non-smoking men and women
2. Healthy (no established diagnosis)
3. 55-70 years old
4. Body Mass Index (BMI) of 25-40 kg/m2

Exclusion Criteria

1. Current participation in other clinical investigations
2. Physical disabilities, trauma or surgery that limit mobility and impede physical performance (i.e. not able to comply with the assessment of physical strength and influence on cardio-metabolic functions)
3. Vegetarianism (likely to have very high nitrate intake)
4. Aversion to beetroot consumption or inability to comply with the study diet (lack of compliance)
5. Weight change more than 3.0 kg in the last 3 months (important influence on systemic metabolism and vascular function)
6. Active cancer and any diagnosis of malignant cancer in the last 5 years (systemic effects on study outcomes)
7. Chronic and acute metabolic and inflammatory conditions interfering with the study outcome (systemic effects on study outcomes). For example, severe hypertension (SBP/DBP=>180 mmHg/>110), kidney stones, gallstones or rheumatoid arthritis
8. Previous diagnosis of type 1 or type 2 diabetes treated with insulin (modification of regulation of intermediate metabolism)
9. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism)
10. Drugs: oral corticosteroids, sildenafil, diuretics, laxatives, anticoagulants, nitrate-derived agents, anti-cholinergic (all drugs have either an effect on NO production or insulin sensitivity via different mechanisms)
11. Subjects on hormonal therapies (oestrogens, thyroxine, progesterone, oral hypoglycaemic agents), anti-hypertensive (beta-blockers, calcium antagonists, ACE inhibitors and angiotensin receptor inhibitors), statins and any other anti-dyslipidaemic agent and psychiatric drugs (antidepressants, sedatives, antipsychotics) will be excluded if dose has been started/changed in the previous 3 months (make sure that these disorders are under strict control to avoid interference with the study outcomes)
12. Haematological disorders including severe anaemia (Hb < 10 mg/dL) (risk for the participant and effects on the study outcomes)
13. Major surgical operations interfering with the study outcomes (systemic effects on study outcomes)
14. Alcohol intake >21 units/week for men and >14 units/week for women
15. Non-English speakers or volunteers requiring translators or interpreters (since these services are not available for this study)

Study & Design

• Study Type: Interventional
• Study Design: Not specified