Clinical trial NCT02913287: Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Cognition as measured using CANTAB tests
timeFrame: On study completion, after each individual completes 12 weeks of supplement
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: University College Cork
Study officials:
affiliation: University College Cork
name: Yvonne Nolan
role: PRINCIPAL_INVESTIGATOR
References: