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

Primary Purpose

Memory Impairment, Age-related Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blue fish hydrolysate
Placebo
Sponsored by
Abyss Ingredients
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Memory Impairment focused on measuring Memory, Cognitive decline, Food supplement, Hydrolysate, Aging

Eligibility Criteria

60 Years - 73 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Laboratoire Nutrition et Neurobiologie IntégréeRecruiting
  • Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de BordeauxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Blue fish hydrolysate

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CANTAB - Paired Associate Learning test (PAL)
CANTAB - Verbal Recognition Memory (VRM)
CANTAB - Spatial Working Memory test (SWM)
CANTAB - Spatial Span test (SSP)
CANTAB - Reverse Spatial Span test (Reverse SSP)
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.
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.
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.
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.

Full Information

First Posted
May 14, 2021
Last Updated
August 19, 2022
Sponsor
Abyss Ingredients
Collaborators
Laboratoire Nutrition et Neurobiologie intégrée, University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04910399
Brief Title
Development of an Innovative Health Ingredient From Marine By-products for the Healthy Aging
Acronym
BRAINBOOSTER
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abyss Ingredients
Collaborators
Laboratoire Nutrition et Neurobiologie intégrée, University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Impairment, Age-related Cognitive Decline
Keywords
Memory, Cognitive decline, Food supplement, Hydrolysate, Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blue fish hydrolysate
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blue fish hydrolysate
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
CANTAB - Paired Associate Learning test (PAL TEA = PAL Total Error Adjusted)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
CANTAB - Paired Associate Learning test (PAL)
Time Frame
12 weeks
Title
CANTAB - Verbal Recognition Memory (VRM)
Time Frame
12 weeks
Title
CANTAB - Spatial Working Memory test (SWM)
Time Frame
12 weeks
Title
CANTAB - Spatial Span test (SSP)
Time Frame
12 weeks
Title
CANTAB - Reverse Spatial Span test (Reverse SSP)
Time Frame
12 weeks
Title
Perceived Stress Level Scale (PSS)
Description
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.
Time Frame
12 weeks
Title
Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
12 weeks
Title
Geriatric Depression Scale (GDS)
Description
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.
Time Frame
12 weeks
Title
Participant's Satisfaction via a multiple choice questionnaire
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Concentration of fasting blood glucose
Time Frame
baseline and 12 weeks
Title
Concentration of fasting blood Total-cholesterol
Time Frame
baseline and 12 weeks
Title
Concentration of fasting blood HDL-cholesterol
Time Frame
baseline and 12 weeks
Title
Concentration of fasting blood LDL-cholesterol
Time Frame
baseline and 12 weeks
Title
Concentration of fasting blood triglycerides
Time Frame
baseline and 12 weeks
Title
Concentration of cytokines
Description
An inflammatory marker in plasma
Time Frame
baseline and 12 weeks
Title
Concentration of oxylipins
Description
An inflammatory marker in plasma
Time Frame
baseline and 12 weeks
Title
Concentration of salivary cortisol
Description
Collection 30 minutes after awakening
Time Frame
baseline and 12 weeks
Title
Concentration of urinary cortisol
Description
Collection after awakening
Time Frame
baseline and 12 weeks
Title
Concentration of urinary cortisol metabolites
Description
Dosage of tetrahydrocortisone and tetrahydrocortisol. Collection after awakening
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie BOUVRET, MD
Phone
+33777849366
Email
elodie@abyss-ingredients.com
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique Pallet, Pr
Phone
0557571230
Email
veronique.pallet@enscbp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre PHILIP, Pr
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire Nutrition et Neurobiologie Intégrée
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique PALLET, Pr
Phone
0557571232
Email
veronique.pallet@enscbp.fr
First Name & Middle Initial & Last Name & Degree
Corinne JOFFRE, PhD
Phone
0557574505
Email
corinne.joffre@inrae.fr
Facility Name
Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre PHILIP, Pr
Phone
0557820172
Email
pierre.philip@u-bordeaux.fr

12. IPD Sharing Statement

Learn more about this trial

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

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