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Completed

NCT Number: NCT02913287

Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

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.

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Key information

Conditions

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Cork

Cork, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aquamin/Aquamin MG

Dietary Supplement

Marine-based nutraceutical

Maltodextrin Placebo

Other

Maltodextrin Placebo

Primary outcomes

  1. Cognition as measured using CANTAB tests

    Time frame: On study completion, after each individual completes 12 weeks of supplement

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 23, 2016
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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