Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

Cognition Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02913287
• Other study ID #: YN001
• Status: Active, not recruiting
• Phase: N/A
• First received: September 19, 2016
• Last updated: September 21, 2016
• Start date: November 2015

Study information

• Verified date: September 2016
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition

Intervention

Dietary Supplement:
• Aquamin/Aquamin MG
Marine-based nutraceutical

Other:
• Maltodextrin Placebo
Maltodextrin Placebo

Locations

Country	Name	City	State
Ireland	University College Cork	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition as measured using CANTAB tests		On study completion, after each individual completes 12 weeks of supplement	No