NCT02913287已完成不适用
A Randomised, Double-blind, Placebo-controlled Study of the Cognitive-Enhancing Potential of Seaweed-Derived Mineral-Rich Nutraceuticals (a Combination of Aquamin F and Aquamin MG)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cognition as measured using CANTAB tests
研究概览
简要总结
The aim of the overall project is to investigate the potential of a combination of commercially available nutraceuticals produced by Marigot Ltd (natural seawater derived mineral-rich AquaminMG and seaweed-derived mineral-rich food supplement AquaminTM (FDA GRAS 000028) isolated from Lithothamnion species), as safe and effective supplements to promote cognition in the aged brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be considered eligible for enrolment into the study, subjects must;
- •Be able to give written informed consent.
- •Be between 65 and 85 years of age (elderly cohort).
- •If female, must be non-pregnant.
- •Be in generally good health as determined by the investigator.
排除标准
- •Subjects will be excluded from the study if they meet any of the below criteria;
- •Are less than 65 and greater than 85 years of age (elderly cohort).
- •Are pregnant females.
- •Are currently taking calcium/magnesium supplements, or have taken them in the past 14 days.
- •Have a significant acute or chronic co-existing illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgement, entry to the study).
- •Have a score of <22 in the Montreal Cognitive Assessment (MoCA) (elderly cohort) and have no subjective memory impairment.
- •Have a history of renal failure or renal disease, or eGFR creatinine levels below 30ml/min.
- •Have diagnosis of significant low or high calcium or magnesium levels.
- •Have a condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include misoprostrol, polystyrene sulfonate, Riociguat and vitamin/mineral supplements, probiotics or herbal remedies.
- •Are individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
- •Are receiving treatment involving experimental drugs.
- •Have been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
- •Have a malignant disease or any concomitant end-stage organ disease.
- •Have a psychiatric illness which contraindicates entry to the study.
结局指标
主要结局
Cognition as measured using CANTAB tests
时间窗: On study completion, after each individual completes 12 weeks of supplement
次要结局
未报告次要终点
研究者
研究点 (1)
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