Effects of inorganic nitrate on physical performance in older subjects

Not Applicable

Completed

• Conditions: utrition, ageing, vascular function, muscular function, metabolic assessment; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN19064955
• Lead Sponsor: The Centre for Integrated Research into Musculoskeletal Ageing (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-16
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Non-smoking men and women aged between 60 and 75 years of age
2. English speakers and with a body mass index (BMI) of between 18.5 and 29.9 kg/m2. We have stated that participants must be English speakers because we cannot offer translation services for this study.

Exclusion Criteria

1. Current participation in other research clinical studies
2. Very high resting blood pressure readings (systolic >180 mmHg and/or diastolic >110 mmHg)
3. Vegetarianism (likely to have very high nitrate intake)
4. High physical activity level (>15,000 steps per day; may have BMI in overweight range but low fat mass)
5. Weight change more than 3.0 kg in the last 2 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. Diagnosis of chronic and acute metabolic and inflammatory conditions interfering with the study outcome (systemic effects on study outcomes). For example flu, Crohn's disease, rheumatoid arthritis
8. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism)
9. Previous diagnosis of type 1 or type 2 diabetes treated with insulin and oral hypoglycaemic agents (modification of regulation of intermediate metabolism). Type 2 diabetic patients treated with diet only will be included in the study.
10. Drugs: corticosteroids, sildenafil, aspirin, NSAIDs, diuretics, beta-blockers, antacids, anti-hypertensive (Ca++ channel blockers, ACE inhibitors), statins and any other anti-dyslipidaemic agent, anticoagulants, nitrate-derived agents, anti-cholinergic (all drugs may have an effect on NO production via different mechanisms)
11. Subjects on hormonal therapies (oestrogens, thyroxine, progesteron) and psychiatric drugs (antidepressants, sedatives, antipsychotics) will be excluded if dose has been started/changed in the previous three months (make sure that these disorders are under strict control to avoid interference with the study outcomes)
12. Haematological disorders including self-reported anaemia (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. Blood donations in the previous 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified