The impact of cranberries on microbiome and brain in healthy ageing

Not Applicable

Completed

• Conditions: Brain function in healthy older people; Nervous System Diseases

• Registration Number: ISRCTN76069316
• Lead Sponsor: niversity of East Anglia

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35662954/ (added 07/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-13
• Study Completion: 2020-05-21
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified