Memory ImpairmentBRAINBOOSTERNCT04910399
Development of an Innovative Health Ingredient From Marine By-products for the Healthy Aging
A study testing Blue fish hydrolysate in people with Memory Impairment and Age-related Cognitive Decline, run by Abyss Ingredients at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Impairment, Age-related Cognitive Decline
- What is being tested?
- Blue fish hydrolysate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Sep 2021to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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
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- 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,
Trial locations and contacts
2 sites in 1 country.
France2 sites
Laboratoire Nutrition et Neurobiologie Intégrée
Bordeaux, 33076
Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de Bordeaux
Bordeaux, 33076
About this study
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.
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.
Read the 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
- Being tested
- Blue fish hydrolysate, Placebo
- Keywords
- Memory, Cognitive decline, Food supplement, Hydrolysate, Aging
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue fish hydrolysateDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CANTAB - Paired Associate Learning test (PAL TEA = PAL Total Error Adjusted)
Measured: 12 weeks
Secondary outcomes (9)
CANTAB - Paired Associate Learning test (PAL)
Measured: 12 weeks
CANTAB - Verbal Recognition Memory (VRM)
Measured: 12 weeks
CANTAB - Spatial Working Memory test (SWM)
Measured: 12 weeks
CANTAB - Spatial Span test (SSP)
Measured: 12 weeks
CANTAB - Reverse Spatial Span test (Reverse SSP)
Measured: 12 weeks
Perceived Stress Level Scale (PSS)
The Perceived Stress Scale is a 10-item self-administered questionnaire that assesses the frequency with which the respondent has experienced feelings of stress or loss of control over events in the past month. Each item is rated by the patient on a Likert scale from 0 to 4. The total score is obtained by adding the score for each item. The total score is between 0 and 40. A score below 13 suggests a low stress level, a score between 14 and 19 a moderate stress level and a score above 20 a high stress level.
Measured: 12 weeks
Mini-Mental State Examination (MMSE)
The MMSE consists of 30 questions or tasks (items) exploring possible disorders of: orientation in time and space, memory, attention, language (speech, comprehension, reading, writing), motor performance. For each of the thirty questions, a correct answer results in a score of 1 and a wrong or approximate answer in a score of 0. The final score is marked out of 30 points.
Measured: 12 weeks
Geriatric Depression Scale (GDS)
The GDS Short Form is a self-administered questionnaire with 15 items, each with a binary Yes-No response. It was designed to test for depressive symptoms in elderly subjects. In the original form of the scale, an individual with a score of 0 to 5 is considered normal. A score between 5 and 9 indicates a high probability of depression and a score between 10 and 15 almost always indicates depression.
Measured: 12 weeks
Participant's Satisfaction via a multiple choice questionnaire
Each volunteer will filled a multiple choice questionnaire at the end of the study. The galenic choice, organoleptic aspects and the global intake of the product they took will be evaluated.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start14 Sep 2021
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abyss Ingredients
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratoire Nutrition et Neurobiologie intégrée, University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Pierre PHILIP, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910399
- Sponsor's protocol ID
- BRAINBOOSTER
- Acronym
- BRAINBOOSTER
- Status last verified
- Jan 2024
- First submitted
- 14 May 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chataigner M, Peltier A, Bouvret E, Dinel AL, Joffre C, Pallet V. Dietary fish hydrolysate improves episodic memory in healthy elderly with lower level of memory performance: a double-blind, randomized, placebo-controlled clinical study. Am J Clin Nutr. 2026 Jul;124(1):101360. doi: 10.1016/j.ajcnut.2026.101360. Epub 2026 May 19.
PubMed 42162916
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04910399
- Acronym / sponsor ID
- BRAINBOOSTER / BRAINBOOSTER
- Conditions
- Memory Impairment, Age-related Cognitive Decline
- Keywords
- Memory, Cognitive decline, Food supplement, Hydrolysate, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Abyss IngredientsIndustry (pharma, biotech, devices)
- Collaborators
- Laboratoire Nutrition et Neurobiologie intégrée, University Hospital, Bordeaux
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue fish hydrolysate | Experimental | Dietary Supplement: Blue fish hydrolysateThe 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. |
Who may qualify
- Ages
- 60 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue fish hydrolysateThe 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. | Dietary supplement | Blue fish hydrolysate |
| PlaceboThe 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. | Dietary supplement | Placebo |
Primary outcome
CANTAB - Paired Associate Learning test (PAL TEA = PAL Total Error Adjusted)
Time frame: 12 weeks
9 secondary outcomes
CANTAB - Paired Associate Learning test (PAL)
Time frame: 12 weeks
CANTAB - Verbal Recognition Memory (VRM)
Time frame: 12 weeks
CANTAB - Spatial Working Memory test (SWM)
Time frame: 12 weeks
CANTAB - Spatial Span test (SSP)
Time frame: 12 weeks
CANTAB - Reverse Spatial Span test (Reverse SSP)
Time frame: 12 weeks
Perceived Stress Level Scale (PSS)
Time frame: 12 weeks
Mini-Mental State Examination (MMSE)
Time frame: 12 weeks
Geriatric Depression Scale (GDS)
Time frame: 12 weeks
Participant's Satisfaction via a multiple choice questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 42162916Chataigner M, Peltier A, Bouvret E, Dinel AL, Joffre C, Pallet V. Dietary fish hydrolysate improves episodic memory in healthy elderly with lower level of memory performance: a double-blind, randomized, placebo-controlled clinical study. Am J Clin Nutr. 2026 Jul;124(1):101360. doi: 10.1016/j.ajcnut.2026.101360. Epub 2026 May 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre PHILIP, Pr principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue fish hydrolysate in people with Memory Impairment and Age-related Cognitive Decline, run by Abyss Ingredients at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CANTAB - Paired Associate Learning test (PAL TEA = PAL Total Error Adjusted) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.