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| Name | Class |
|---|---|
| Laboratoire Nutrition et Neurobiologie intégrée | UNKNOWN |
| University Hospital, Bordeaux | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CANTAB - Paired Associate Learning test (PAL TEA = PAL Total Error Adjusted) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CANTAB - Paired Associate Learning test (PAL) | 12 weeks | |
| CANTAB - Verbal Recognition Memory (VRM) | 12 weeks | |
| CANTAB - Spatial Working Memory test (SWM) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre PHILIP, Pr | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratoire Nutrition et Neurobiologie Intégrée | Bordeaux | 33076 | France | |||
| Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42162916 | Derived | 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 May 19;124(1):101360. doi: 10.1016/j.ajcnut.2026.101360. Online ahead of print. |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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|
| 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. |
|
| 12 weeks |
| CANTAB - Spatial Span test (SSP) | 12 weeks |
| CANTAB - Reverse Spatial Span test (Reverse SSP) | 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. | 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. | 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. | 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. | 12 weeks |
| baseline and 12 weeks |
| Concentration of fasting blood LDL-cholesterol | baseline and 12 weeks |
| Concentration of fasting blood triglycerides | baseline and 12 weeks |
| Concentration of cytokines | An inflammatory marker in plasma | baseline and 12 weeks |
| Concentration of oxylipins | An inflammatory marker in plasma | baseline and 12 weeks |
| Concentration of salivary cortisol | Collection 30 minutes after awakening | baseline and 12 weeks |
| Concentration of urinary cortisol | Collection after awakening | baseline and 12 weeks |
| Concentration of urinary cortisol metabolites | Dosage of tetrahydrocortisone and tetrahydrocortisol. Collection after awakening | baseline and 12 weeks |
| Bordeaux |
| 33076 |
| France |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |