Age-related impairment of cognitive function and cerebral blood flow, cerebral hypo-perfusion Circulatory System Age-related impairment of cognitive function and cerebral blood flow Cerebral hypo-perfusion
Conditions
Interventions
This is a single-blind, randomised, placebo controlled clinical trial. Sixty participants are randomly allocated to 4 intervention groups (15 participant per group). Participants will be asked to cons
Sponsors
Royal Embassy of Saudi Arabia Cultural Bureau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy 2. BMI 25-40 kg/m² 3. Aged 60-75 years 4. Non-smoker 5. Non-vegetarian
Exclusion criteria
Exclusion criteria: 1. Current participation in other research clinical studies 2. Systolic blood pressure lower than 115 mmHg and greater than 160 mmHg 3. Diastolic BP lower than 70 mmHg and greater than 100 mmHg 4. Active cancer and any diagnosis of malignant cancer in the last 5 years 5. Excessive alcohol intake 6. Allergy or intolerance to the intervention food 7. Diagnosis of chronic and acute metabolic and inflammatory conditions interfering with the study outcome, including flu, Crohn’s disease, rheumatoid arthritis and epilepsy 8. Major surgical operations interfering with the study outcomes 9. Taking any of the following if the dose has been started/changed in the previous 3 months: 9.1. Hormonal therapies (oestrogens, thyroxin, and progesterone) 9.2. Anti-hypertensive drugs (Ca++ channel blockers, beta-blockers, and angiotensin-converting-enzyme (ACE) inhibitors) 9.3. Statins 9.4. Any other anti-dyslipidaemic agent 9.5. Psychiatric drugs (antidepressants, sedatives, antipsychotics) Non-prescribed vitamin or other dietary supplements will be stopped during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability and feasibility of the proposed intervention study in terms of: 1. Whether participants will be able to consume beetroot for 13 weeks 2. Whether participants will be retained in the study Participants will be provided with a checklist to record and monitor beetroot juice consumption throughout the study, and an exit feedback questionnaire will be completed at the end of the study to obtain detailed information on the acceptability and compliance to the interventions and measurement protocols. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the following from the baseline to the end of the study, assessed at the baseline and the end of the study: 1. Cognitive function, assessed using the Computerised Mental Performance Assessment System software (COMPASS, University of Northumbria) 2. Cerebral blood flow, assessed using a frequency domain ‘quantitative’ NIRS system (OxiplexTS Frequency-Domain Near-Infrared Tissue Oximeter, ISS Science) 3. Body composition, assessed using a bioelectrical impedance analyser 4. Resting clinic and home blood pressure, assessed in duplicate using an automated BP monitor (Omron M3) 5. Endothelial function, assessed using lontophoresis 6. Metabolic biomarkers: 6.1. Nitrite and nitrate, assessed by ozone-based chemiluminescence 6.2. cGMP, assessed using commercially available and validated immunoassays 7. Metabolic risk factors (blood glucose concentration, assessed using commercially available kits 8. The following oxidative stress biomarkers, assessed using commercially available and validated immunoassays: 8.1. 4-Hydroxynonenal 8.2. 3-Nitrotyrosine 9. Inflammatory biomarkers (IL-6), assessed using commercially available and validated immunoassays 10. Endothelial-dependent and -independent microvascular blood flow, assessed by Laser Doppler Iontophoresis (LDI) and pulse wave velocity measured by photo-plethysmography 11. Whole-body NO production, assessed from saliva samples using a stable isotopic method (gas chromatography/mass spectrometry (GC/MS)) | — |
Countries
England, United Kingdom
Contacts
Public ContactAbrar Babateen
Outcome results
None listed