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Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

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ClinicalTrials.gov Identifier: NCT02913287
Recruitment Status : Unknown
Verified September 2016 by Yvonne Nolan, University College Cork.
Recruitment status was:  Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Yvonne Nolan, University College Cork

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.

Condition or disease Intervention/treatment Phase
Cognition Dietary Supplement: Aquamin/Aquamin MG Other: Maltodextrin Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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)
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Placebo Comparator: Placebo
Maltodextrin
Other: Maltodextrin Placebo
Maltodextrin Placebo

Experimental: Aquamin/Aquamin MG
Aquamin/Aquamin MG mix
Dietary Supplement: Aquamin/Aquamin MG
Marine-based nutraceutical




Primary Outcome Measures :
  1. Cognition as measured using CANTAB tests [ Time Frame: On study completion, after each individual completes 12 weeks of supplement ]


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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913287


Locations
Ireland
University College Cork
Cork, Ireland
Sponsors and Collaborators
University College Cork
Investigators
Principal Investigator: Yvonne Nolan University College Cork

Responsible Party: Yvonne Nolan, Chief Investigator, Senior Lecturer & Programme Director of BSc. Neuroscience, University College Cork
ClinicalTrials.gov Identifier: NCT02913287     History of Changes
Other Study ID Numbers: YN001
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided