Overview

This trial is active, not recruiting.

Condition cognition
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
Maltodextrin
maltodextrin placebo
Maltodextrin Placebo
(Experimental)
Aquamin/Aquamin MG mix
aquamin/aquamin mg
Marine-based nutraceutical

Primary Outcomes

Measure
Cognition as measured using CANTAB tests
time frame: On study completion, after each individual completes 12 weeks of supplement

Eligibility Criteria

Male or female participants from 65 years up to 85 years old.

Inclusion Criteria: To be considered eligible for enrolment into the study, subjects must; 1. Be able to give written informed consent. 2. Be between 65 and 85 years of age (elderly cohort). 3. If female, must be non-pregnant. 4. 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; 1. Are less than 65 and greater than 85 years of age (elderly cohort). 2. Are pregnant females. 3. Are currently taking calcium/magnesium supplements, or have taken them in the past 14 days. 4. 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). 5. Have a score of <22 in the Montreal Cognitive Assessment (MoCA) (elderly cohort) and have no subjective memory impairment. 6. Have a history of renal failure or renal disease, or eGFR creatinine levels below 30ml/min. 7. Have diagnosis of significant low or high calcium or magnesium levels. 8. 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. 9. 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. 10. Are receiving treatment involving experimental drugs. 11. Have been in a recent experimental trial, these must have been completed not less than 30 days prior to this study. 12. Have a malignant disease or any concomitant end-stage organ disease. 13. Have a psychiatric illness which contraindicates entry to the study.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University College Cork.