Status:
COMPLETED
Development of an Innovative Health Ingredient From Marine By-products for the Healthy Aging
Lead Sponsor:
Abyss Ingredients
Collaborating Sponsors:
Laboratoire Nutrition et Neurobiologie intégrée
University Hospital, Bordeaux
Conditions:
Memory Impairment
Age-related Cognitive Decline
Eligibility:
All Genders
60-73 years
Phase:
NA
Brief 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, contai...
Detailed Description
The main objective of this study is to evaluate the efficacy of a dietary supplementation with a hydrolysate derived from marine by-products compared to a placebo on the evolution of episodic memory a...
Eligibility Criteria
Inclusion
- 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
- 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 interview according to the criteria of module A of the MINI (Mini International Neuropsychiatric Interview)
- Unbalanced thyroid disease (treatment modified in the last 6 months),
- For women: hormone replacement therapy started less than 3 months ago or for which the dosage of the treatment has been modified in the last 3 months or whose dosage is likely to be modified during the study
- Chronic inflammatory bowel disease or chronic disorders of intestinal absorption
- Diagnosed inflammatory bowel disease or chronic intestinal absorption disorders
- Current antidepressant treatment or discontinuation within the last 3 months
- Substance abuse or alcoholism within the last 6 months (smoking is allowed)
- General anesthesia in the last 6 months or scheduled in the next 6 months
- Alcohol abuse: more than 2 standard drinks per day,
- Subjects with clinical characteristics that may interfere with the performance of the tests (e.g.: acute visual or hearing impairment)
- Person placed under court protection,
- Person participating in another research study with an exclusion period still in progress ongoing,
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04910399
Start Date
September 14 2021
End Date
August 10 2023
Last Update
January 9 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Laboratoire Nutrition et Neurobiologie Intégrée
Bordeaux, France, 33076
2
Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de Bordeaux
Bordeaux, France, 33076