Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition
This trial is active, not recruiting.
|Treatments||aquamin/aquamin mg, maltodextrin placebo|
|Sponsor||University College Cork|
|Start date||November 2015|
|End date||November 2016|
|Trial size||60 participants|
|Trial identifier||NCT02913287, YN001|
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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Aquamin/Aquamin MG mix
Cognition as measured using CANTAB tests
time frame: On study completion, after each individual completes 12 weeks of supplement
Male or female participants from 65 years up to 85 years old.
- 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.
- 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.
|Official title||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)|
|Principal investigator||Yvonne Nolan|
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