Development of an Innovative Health Ingredient From Marine By-products for the Healthy Aging

NCT ID: NCT04910399

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2023-08-10

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.

Conditions

Memory Impairment; Age-related Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Blue fish hydrolysate

The test product is a food supplement named BrainBooster in our project. It is presented as a capsule containing a blue fish hydrolysate, containing peptides and n-3 polyunsaturated fatty acids.

Group Type: EXPERIMENTAL

Blue fish hydrolysate

Intervention Type: DIETARY_SUPPLEMENT

The experimental product is a dietary supplement composed of a hydrolysate of fatty blue fish containing low molecular weight peptides and n-3 polyunsaturated fatty acids.

One of the two study groups (28 volunteers) will take 4 capsules of the active product (blue fish hydrolysate), for 90 days.

Each day the capsules will be taken as followed : 2 capsules in the morning and 2 capsules in the evening.

Placebo

The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The placebo product containing mainly maltodextrin is presented in the same form as the active product, so that people handling the product cannot distinguish between them. The placebo is flavoured in order to have a fishy smell just like the active product.

One of the two study groups (28 volunteers) will take 4 capsules of placebo per day, for 90 days.Each day the capsules will be taken as followed : 2 capsules in the morning and 2 capsules in the evening.

Interventions

Blue fish hydrolysate

The experimental product is a dietary supplement composed of a hydrolysate of fatty blue fish containing low molecular weight peptides and n-3 polyunsaturated fatty acids.

One of the two study groups (28 volunteers) will take 4 capsules of the active product (blue fish hydrolysate), for 90 days.

Each day the capsules will be taken as followed : 2 capsules in the morning and 2 capsules in the evening.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo product containing mainly maltodextrin is presented in the same form as the active product, so that people handling the product cannot distinguish between them. The placebo is flavoured in order to have a fishy smell just like the active product.

One of the two study groups (28 volunteers) will take 4 capsules of placebo per day, for 90 days.Each day the capsules will be taken as followed : 2 capsules in the morning and 2 capsules in the evening.

Intervention Type: DIETARY_SUPPLEMENT

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,

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratoire Nutrition et Neurobiologie intégrée

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

Abyss Ingredients

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre PHILIP, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Laboratoire Nutrition et Neurobiologie Intégrée

Bordeaux, , France

Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

BRAINBOOSTER

Identifier Type: -

Identifier Source: org_study_id