Development of an Innovative Health Ingredient From Marine By-products for the Healthy Aging (NCT04910399) | Clinical Trial Compass
CompletedNot Applicable
Development of an Innovative Health Ingredient From Marine By-products for the Healthy Aging
France53 participantsStarted 2021-09-14
Plain-language summary
This interventional, randomised, placebo-controlled and double-blind study aims to evaluate the effect of a dietary supplementation with a blue fish hydrolysate derived from marine by-products, containing peptides and n-3 polyunsaturated fatty acids, on cognitive performance in a healthy older population, between 60 and 73 years old, with lower memory performance.
Who can participate
Age range60 Years – 73 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subjects, aged between 60 and 73 years old (including age limits),
* BMI between 20 and 30 kg/m2,
* Not diagnosed with Alzheimer's disease and autonomous,
* 26 \< MMSE \<= 29,
* PAL TEA \> 57,
* Affiliated with a social security plan,
* Able to understand the study and consent,
* Available to come to the 5 visits required for the study,
* Informed and have signed an informed consent.
Exclusion Criteria:
* Person who has participated in the last 3 months or is currently participating in another clinical trial that may interfere with the evaluation of the primary endpoint (memory).
* Subject consuming food supplements likely to have an effect on memory or within less than 6 months
* Subject consuming high level of Vitamin A and/or Long chain n-3 PUFA evaluated by a food frequency questionnaire
* Restrictive or unbalanced diet (hypocaloric, vegetarian, vegan, …) self-declared at V0
* Fish consumption more than twice a week
* Allergy to fish
* Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing,
* Diabetes (type 1 or type 2),
* Cardiovascular disease diagnosed within less that 2 years, with the following exceptions: subjects with controlled (medicated) high blood pressure and/ or controlled (medicated) can be included,
* Personal history of stroke
* Personal history of schizophrenia or other psychiatric disorders
* Ongoing neuroleptic treatment
* Current depressive episode characterized at clinical…
What they're measuring
1
CANTAB - Paired Associate Learning test (PAL TEA = PAL Total Error Adjusted)