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

NCT04910399 | Completed DMC

• 1 other identifier: BRAINBOOSTER
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Memory Impairment; Age-related Cognitive Decline

Keywords

Memory; Cognitive decline; Food supplement; Hydrolysate; Aging

Outcome Measures

Primary Outcomes (1)

• CANTAB - Paired Associate Learning test (PAL TEA = PAL Total Error Adjusted)

  12 weeks

Secondary Outcomes (9)

• CANTAB - Paired Associate Learning test (PAL)

  12 weeks

• CANTAB - Verbal Recognition Memory (VRM)

  12 weeks

• CANTAB - Spatial Working Memory test (SWM)

  12 weeks

• CANTAB - Spatial Span test (SSP)

  12 weeks

• CANTAB - Reverse Spatial Span test (Reverse SSP)

  12 weeks

Other Outcomes (10)

• Concentration of fasting blood glucose

  baseline and 12 weeks

• Concentration of fasting blood Total-cholesterol

  baseline and 12 weeks

• Concentration of fasting blood HDL-cholesterol

  baseline and 12 weeks

Study Arms (2)

Blue fish hydrolysate

EXPERIMENTAL

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.

Dietary Supplement: Blue fish hydrolysate

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Blue fish hydrolysate 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.

Blue fish hydrolysate

Placebo 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.

Placebo

Eligibility Criteria

• Age: 60 Years - 73 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• \< 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abyss Ingredients: lead
• Laboratoire Nutrition et Neurobiologie intégrée: collaborator
• University Hospital, Bordeaux: collaborator

Study Sites (2)

Laboratoire Nutrition et Neurobiologie Intégrée

Bordeaux, 33076, France

Location

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

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Memory Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pierre PHILIP, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: June 2, 2021
• Study Start: September 14, 2021
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

FR (2)