Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

U

University College Cork (UCC)

Status

Unknown

Conditions

Cognition

Treatments

Other: Maltodextrin Placebo
Dietary Supplement: Aquamin/Aquamin MG

Study type

Interventional

Funder types

Other

Identifiers

NCT02913287
YN001

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

65 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Maltodextrin
Treatment:
Other: Maltodextrin Placebo
Aquamin/Aquamin MG
Experimental group
Description:
Aquamin/Aquamin MG mix
Treatment:
Dietary Supplement: Aquamin/Aquamin MG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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