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)

University College Cork1 site in 1 country30 target enrollmentOctober 15, 2015

ConditionsCognition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cognition
Sponsor: University College Cork
Enrollment: 30
Locations: 1
Primary Endpoint: Cognition as measured using CANTAB tests
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2015

End Date

January 2017

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University College Cork

Responsible Party

Sponsor

Eligibility Criteria

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.