Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

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)

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.

Study Overview

• Status: Unknown
• Conditions: Cognition
• Intervention / Treatment: Other: Maltodextrin Placebo; Dietary supplement: Aquamin/Aquamin MG

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • University College Cork

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University College Cork
• Investigators: Principal Investigator: Yvonne Nolan, University College Cork

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: YN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided