Healthy Elderly
Conditions
Keywords
polyphenols, memory, elderly
Brief summary
Several preliminary studies have shown that diet can have beneficial effects on cognitive decline. Among food shown to have such effects are some polyphenols from selected botanicals. Preclinical studies have concluded that polyphenols play a role in moderation of oxidative stress and inflammation, increased neuronal signaling, and improved metabolic function among other effects. Noteworthy, a positive and statistically significant association between the midlife level of polyphenol intake and cognitive function assessed 13 years later was found in a cohort of 2574 adults. Several mechanisms may be involved in these positive effects of food polyphenols on cognitive function in older adults: experimental studies suggest that polyphenols display neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and inducing neurogenesis, and might prevent age-related damage to the central nervous system through their antioxidant and anti-inflammatory activities. Based on these promising results, a food supplement from botanicals offering complementary polyphenol profile was developed. This food supplement is aimed to aid at maintenance of cognitive function in older adults.
Detailed description
This project aims to investigate the effects of 6 months supplementation with a polyphenol-rich supplement vs. placebo to consume daily on human cognitive function. Polyphenol-rich supplement and placebo will be provided as capsules matched for appearance. The study will be conducted as a randomized, double-blind, parallel-groups (2 arms) placebo-controlled, multicentre interventional design. Two groups, each of 102 volunteers, are studied. One group of volunteers will consume the polyphenol-rich product while the other one will consume the placebo product. Each volunteer will be seen for 3 visits at the investigational site, will have 2 follow-up calls and mid-term dietary survey. Baseline and follow-up visit will include cognitive assessment with the CANTAB battery. CANTAB tests will cover several aspects of memory: visio-spatial learning and episodic memory, verbal recognition memory and visio-spatial working memory. Moreover, psychological and mood components will be evaluated (mnesic complaint, depression, fatigue). Physical activity and food habits will also be recorded. Finally, biological parameters will be assessed (lipid profile, glycemia, insulinemia, CRPus, thyroid stimulating hormone, transthyretin, plasma level of phenolic compounds).
Interventions
DIETARY_SUPPLEMENTPolyphenol-rich extract
Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product.
DIETARY_SUPPLEMENTPlacebo
The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product.
Sponsors
Activ'inside
Atrium Innovations
Fruit d'Or
Laboratoire NutriNeuro Université de Bordeaux/INRA
NutraCanada
Laval University
Neurophenols Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Independent subjects, living at home; * Body Mass Index (BMI) 20-30 kg/m2 (limits included); * 26 \< MMSE score ≤ 29 * Logical memory subtest of the Wechsler Memory Scale (16-69 years battery) sub-scores complying with the following: * Immediate recall score \< 29; * Delayed recall score \< 16;
Exclusion criteria
* Evidence of actual major depressive disorder according to the module A of the Mini International Neuropsychiatric Interview (MINI); * Subject consuming food supplements likely to have an effect on memory; * High physical activity practice; * Restrictive or unbalanced diet (hypocaloric, vegetarian, vegan, …) self-declared at V0; * Diabetes; * Cardiovascular disease diagnosed within less than 2 years, with the following exceptions: subjects with controlled (medicated) high blood pressure and/ or controlled (medicated) can be included; * Personal history of Cerebrovascular Accident (CVA); * Unbalanced thyroid disease; * Anti-depressant treatment stopped since less than 3 months or still ongoing; * Personal history of schizophrenia or other psychiatric disorders; * Ongoing neuroleptic treatment; * Uncorrected visual or auditory dysfunction (according to the volunteer's self-declaration); * History of moderate to severe traumatic brain injury and / or intracranial surgery; * Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing; * General anesthesia in the last 6 months or planned in the next 6 months; * Documented food allergy(ies), namely to one of the components of the study product; * Psychological or linguistic incapability to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CANTAB - Paired Associate Learning test (PAL) | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| CANTAB - Spatial Span test (SSP) | 24 weeks |
| CANTAB - Reverse Spatial Span test (Reverse SSP) | 24 weeks |
| Wechsler Memory Scale - Logical memory subtest | 24 weeks |
| CANTAB - Verbal Recognition Memory (VRM) | 24 weeks |
| Geriatric Depression Scale | 24 weeks |
| Mini-Mental State Examination | 24 weeks |
| Multidimensional Fatigue Inventory (MFI-20) | 24 weeks |
| McNair scale | 24 weeks |
Other
| Measure | Time frame |
|---|---|
| Lipid profile | 24 weeks |
| Epigenetic markers | 24 weeks |
| Insulinemia and glycemia | 24 weeks |
| Inflammatory markers | 24 weeks |
| Hormones | 24 weeks |
| Urinary polyphenols | 24 weeks |
| Fatty acid profile in erythrocyte membranes | 24 weeks |
| Retinol Binding Protein and Transtyretin | 24 weeks |
| Nuclear receptor expression in mononuclear cells | 24 weeks |
| Gene expression in mononuclear cells by microarray approach | 24 weeks |
Countries
Canada, France
Outcome results
None listed