Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

NCT02913287 | Completed

• 1 other identifier: YN001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition

Outcome Measures

Primary Outcomes (1)

• Cognition as measured using CANTAB tests

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Other: Maltodextrin Placebo

Aquamin/Aquamin MG

EXPERIMENTAL

Aquamin/Aquamin MG mix

Dietary Supplement: Aquamin/Aquamin MG

Interventions

Aquamin/Aquamin MG DIETARY_SUPPLEMENT

Marine-based nutraceutical

Aquamin/Aquamin MG

Maltodextrin Placebo OTHER

Maltodextrin Placebo

Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

University College Cork

Cork, Ireland

Location

MeSH Terms

Interventions

Aquamin

Study Officials

• Yvonne Nolan

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 23, 2016
• Study Start: October 15, 2015
• Primary Completion: November 9, 2016
• Study Completion: January 1, 2017
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

IE (1)