ISRCTN76069316已完成未知
The impact of cranberries on the microbiome and the brain in healthy ageing: a feasibility intervention
niversity of East Anglia0 个研究点目标入组 60 人开始时间: 2018年11月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35662954/ (added 07/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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