Clinical trial NCT04910399: Development of an Innovative Health Ingredient From Marine By-products for the Healthy Aging
Official title: Evaluation of the Effect of Peptides and n-3 Polyunsaturated Fatty Acids (n-3 PUFAs) From a Blue Fish Hydrolysate on Memory in Healthy Elderly People : a Randomised, Placebo-controlled, Double-blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Impairment
Age-related Cognitive Decline
Keywords: Memory
Cognitive decline
Food supplement
Hydrolysate
Aging
Lead sponsor: Abyss Ingredients
Sponsor class: INDUSTRY
Collaborators: name: Laboratoire Nutrition et Neurobiologie intégrée
name: University Hospital, Bordeaux
First posted: 2021-06-02
Enrollment: 53
Sex: ALL
Minimum age (years): 60
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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, 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.

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 at 3 months in healthy elderly people with lower memory performance.

The secondary objectives of this study are to evaluate the efficacy of a dietary supplementation with a hydrolysate derived from marine by-products compared to a placebo on the evolution at 3 months of verbal recognition memory, working memory, perceived stress level, biological markers of nutritional and hormonal status in healthy elderly people with lower memory performance. Finally, participants' satisfaction with the product will be assessed.

Participants have to take 4 capsules per day of the hydrolysate containing 770 mg (dose per capsule) or of the placebo for 90 days.

Participants will have a phone screening interview and will attend 5 visits to the Bordeaux University Hospital on the Neuro-Psychopharmacological Research Platform.

Eligibility criteria: 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 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,

Primary outcomes:
measure: CANTAB - Paired Associate Learning test (PAL TEA = PAL Total Error Adjusted)
timeFrame: 12 weeks
Secondary outcomes:
measure: CANTAB - Paired Associate Learning test (PAL)
timeFrame: 12 weeks
measure: CANTAB - Verbal Recognition Memory (VRM)
timeFrame: 12 weeks
measure: CANTAB - Spatial Working Memory test (SWM)
timeFrame: 12 weeks
measure: CANTAB - Spatial Span test (SSP)
timeFrame: 12 weeks
measure: CANTAB - Reverse Spatial Span test (Reverse SSP)
timeFrame: 12 weeks
measure: Perceived Stress Level Scale (PSS)
timeFrame: 12 weeks
measure: Mini-Mental State Examination (MMSE)
timeFrame: 12 weeks
measure: Geriatric Depression Scale (GDS)
timeFrame: 12 weeks
measure: Participant's Satisfaction via a multiple choice questionnaire
timeFrame: 12 weeks
Other outcomes:
measure: Concentration of fasting blood glucose
timeFrame: baseline and 12 weeks
measure: Concentration of fasting blood Total-cholesterol
timeFrame: baseline and 12 weeks
measure: Concentration of fasting blood HDL-cholesterol
timeFrame: baseline and 12 weeks
measure: Concentration of fasting blood LDL-cholesterol
timeFrame: baseline and 12 weeks
measure: Concentration of fasting blood triglycerides
timeFrame: baseline and 12 weeks
measure: Concentration of cytokines
timeFrame: baseline and 12 weeks
measure: Concentration of oxylipins
timeFrame: baseline and 12 weeks
measure: Concentration of salivary cortisol
timeFrame: baseline and 12 weeks
measure: Concentration of urinary cortisol
timeFrame: baseline and 12 weeks
measure: Concentration of urinary cortisol metabolites
timeFrame: baseline and 12 weeks
Locations:
city: Bordeaux
country: France
facility: Laboratoire Nutrition et Neurobiologie Intégrée
city: Bordeaux
country: France
facility: Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre PHILIP, Pr
role: PRINCIPAL_INVESTIGATOR
References: