|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
3 October 2016 |
|
Main ID: |
NCT02913287 |
|
Date of registration:
|
19/09/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition
|
|
Scientific 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) |
|
Date of first enrolment:
|
November 2015 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02913287 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Ireland
| | | | | | | |
|
Contacts
|
|
Name:
|
Yvonne Nolan |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University College Cork |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
65 Years
Age maximum:
85 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cognition
|
|
Intervention(s)
|
|
Other: Maltodextrin Placebo
|
|
Dietary Supplement: Aquamin/Aquamin MG
|
|
Primary Outcome(s)
|
|
Cognition as measured using CANTAB tests
[Time Frame: On study completion, after each individual completes 12 weeks of supplement]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|