Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2016

Interventions

  • Dietary Supplement: Aquamin/Aquamin MG
    • Marine-based nutraceutical
  • Other: Maltodextrin Placebo
    • Maltodextrin Placebo

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Maltodextrin
  • Experimental: Aquamin/Aquamin MG
    • Aquamin/Aquamin MG mix

Clinical Trial Outcome Measures

Primary Measures

  • Cognition as measured using CANTAB tests
    • Time Frame: On study completion, after each individual completes 12 weeks of supplement

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University College Cork
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yvonne Nolan, Chief Investigator, Senior Lecturer & Programme Director of BSc. Neuroscience – University College Cork
  • Overall Official(s)
    • Yvonne Nolan, Principal Investigator, University College Cork

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.