Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Cognition

Intervention / Treatment
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* Dietary Supplement: Aquamin/Aquamin MG
* Other: Maltodextrin Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Maltodextrin | Other: Maltodextrin Placebo<br>* Maltodextrin Placebo<br>|
| Experimental: Aquamin/Aquamin MG<br>Aquamin/Aquamin MG mix | Dietary Supplement: Aquamin/Aquamin MG<br>* Marine-based nutraceutical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition as measured using CANTAB tests |  | On study completion, after each individual completes 12 weeks of supplement |