Brain function in healthy older people Nervous System Diseases
Conditions
Interventions
Participants will be randomised using a computerised randomisation algorithm into one of two intervention arms: the active cranberry powder arm, or the placebo matched for colour, taste, and macronutr
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 50 and 80 years old 2. Male and female 3. Generally fit and healthy 4. Willing and able to provide written informed consent 5. Fluent in written and spoken English 6. Normal or corrected to normal vision and hearing 7. Understands and is willing and able to comply with all study procedures
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they have any of the following: 1. Diagnosis of any form of dementia or significant neurological condition 2. Significant memory complaints 3. History or MRI evidence of brain damage, including significant trauma, stroke, learning difficulties or serious neurological disorder, including a loss of consciousness for more than 24 hours 4. Currently smoking or ceased smoking less than 6 months ago 5. Chronic fatigue syndrome, liver disease, diabetes mellitus, or gall bladder abnormalities 6. History of alcohol or drug dependency 7. Clinically diagnosed psychiatric disorder 8. Existing diagnosed gastrointestinal or gall bladder disorders 9. Known allergy to the intervention supplement 10. Any significant medical condition likely to affect participation 11. Currently a participant or have been a participant in any other study involving an investigational product within the last 4 weeks 12. Absence of a spouse to be a study partner with whom they are also currently living 13. Uncontrolled hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) 14. Major cardiovascular event, such as myocardial infarction, within the last 12 months 15. Liver disease 16. Chronic fatigue syndrome 17. Diabetes mellitus 18. Participants will not be eligible for the study if they are prescribed any of the following: 18.1. Blood pressure lowering medication 18.2. Anti-depressants 18.3. Anti-coagulants 18.4. Anti-psychotics 18.5. Cholinesterase inhibitors 18.6. Anti-convulsants 18.7. Non-steroidal anti-inflammatory drugs 19. Regarding supplements and diet, participants will not be eligible if they take and/or unwilling to stop taking the following: 19.1. Flavonoid containing supplements (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements 19.2. High flavonoid intake defined as > 15 portions of flavonoid rich foods per day 19.3. Any other supplements that could have a significant impact on the outcome measures 20. Participants will not be eligible to undergo the neuroimaging component of the study if they have any of the following: 20.1. Cardiac pacemaker 20.2. Claustrophobia 21. To ensure safety within the MRI scanner, access to medical records or further inquiry will be required if participants indicate that they may have had any of the following: 21.1. Heart surgery 21.2. Brain, head, spine or eye surgery 21.3. Aneurysm clips 21.4. Hydrocephalus shunt 21.5. Metal dust or fragments in the eye 21.6. Metal injuries (e.g. shrapnel, bullets, pellets) 21.7. Electronic, mechanical, or magnetic implants 21.8. Operations involving metal implants, plates, clips, stents, bands or expanders 21.9. Operations within the previous 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gut microflora speciation and metabolism is measured by analysing stool samples at baseline and at the 12-weeks follow-up 2. Changes in hippocampal volume and other key brain structures measured using structural magnetic resonance imaging at baseline and at 12-weeks follow-up 3. Changes in cerebrovascular blood flow measured using magnetic resonance spectroscopy at baseline and at 12 weeks 4. Change in global cognition measured using the Addenbrooke’s Cognitive Examination III at baseline and 12 weeks 5. Change in spatial navigation abilities measured using The Supermarket Test at baseline and 12 weeks 6. Change in spatial navigation abilities measured using the SeaHero Quest iPad app at baseline and 12 weeks 7. Change in executive function and attention measured using the Trail Making Test and the Digit Span backwards test at baseline and 12 weeks 8. Change in visual memory performance measured using the Rey Complex Figure test at baseline and 12 weeks 9. Change in presence of circulating biomarkers of inflammation (hs-CRP) measured in blood samples taken at baseline and 12 weeks 10. Change in presence of circulating biomarkers of neuronal functioning and cognitive decline (BDNF) measured in blood samples collected at baseline and 12 weeks 11. Change in circulating biomarkers of lipid metabolism (total-, HDL-, LDL-cholesterol, triglycerides) measured in blood samples at baseline and 12 weeks 12. Regular dietary patterns measured using a food frequency questionnaire collected at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in energy expenditure and sleep measured using actigraphs worn for one week prior to baseline and one week prior to the 12 week follow-up visit 2. Genetics related to neurodegenerative disease detected using blood samples to be analysed for genes associated with neurodegenerative disease and dementia (e.g. C9ORF72, APOE-4) collected at baseline 3. Biomarkers of gut permeability and endotoxemia (LPS) measured in blood serum/plasma samples at baseline and 12 weeks 4. Levels of sunlight exposure measured using a brief questionnaire regarding levels of daily sunlight exposure, to be collected at baseline and 12 weeks 5. Sleep duration and quality collected using the Pittsburgh Sleep Questionnaire at baseline and 12 weeks 6. Sleep duration and quality measured using actigraphs worn by participants for one week prior to each baseline and 12 weeks follow-up visits | — |
Countries
England, United Kingdom
Outcome results
None listed