Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults

Healthy Elderly Clinical Trial

— Neurophenol  

Official title:

Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults: Randomized, Placebo-controlled, Double-blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063646
• Other study ID #: INAF-2012-242
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: May 25, 2015
• Start date: February 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2014
• Source: Neurophenols Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Elderly

Intervention

Dietary Supplement:
• Polyphenol-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.
• Placebo
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.

Locations

Country	Name	City	State
Canada	INAF (Institute of nutrition and functionnal foods)	Québec	Quebec
France	Biofortis	Saint-Herblain

Sponsors (7)

Lead Sponsor	Collaborator
Neurophenols Consortium	Activ'inside, Atrium Innovations, Fruit d'Or, Laboratoire NutriNeuro Université de Bordeaux/INRA, Laval University, NutraCanada

Countries where clinical trial is conducted

Canada,  France, 

References & Publications (5)

Kesse-Guyot E, Fezeu L, Andreeva VA, Touvier M, Scalbert A, Hercberg S, Galan P. Total and specific polyphenol intakes in midlife are associated with cognitive function measured 13 years later. J Nutr. 2012 Jan;142(1):76-83. doi: 10.3945/jn.111.144428. Epub 2011 Nov 16. — View Citation

Krikorian R, Boespflug EL, Fleck DE, Stein AL, Wightman JD, Shidler MD, Sadat-Hossieny S. Concord grape juice supplementation and neurocognitive function in human aging. J Agric Food Chem. 2012 Jun 13;60(23):5736-42. doi: 10.1021/jf300277g. Epub 2012 Apr 9. — View Citation

Rossi L, Mazzitelli S, Arciello M, Capo CR, Rotilio G. Benefits from dietary polyphenols for brain aging and Alzheimer's disease. Neurochem Res. 2008 Dec;33(12):2390-400. doi: 10.1007/s11064-008-9696-7. Epub 2008 Apr 16. Review. — View Citation

Spencer JP, Vauzour D, Rendeiro C. Flavonoids and cognition: the molecular mechanisms underlying their behavioural effects. Arch Biochem Biophys. 2009 Dec;492(1-2):1-9. doi: 10.1016/j.abb.2009.10.003. Epub 2009 Oct 12. Review. — View Citation

Vauzour D, Vafeiadou K, Rodriguez-Mateos A, Rendeiro C, Spencer JP. The neuroprotective potential of flavonoids: a multiplicity of effects. Genes Nutr. 2008 Dec;3(3-4):115-26. doi: 10.1007/s12263-008-0091-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipid profile		24 weeks	No
Other	Insulinemia and glycemia		24 weeks	No
Other	Inflammatory markers		24 weeks	No
Other	Hormones		24 weeks	No
Other	Urinary polyphenols		24 weeks	No
Other	Fatty acid profile in erythrocyte membranes		24 weeks	No
Other	Retinol Binding Protein and Transtyretin		24 weeks	No
Other	Nuclear receptor expression in mononuclear cells		24 weeks	No
Other	Gene expression in mononuclear cells by microarray approach		24 weeks	No
Other	Epigenetic markers		24 weeks	No
Primary	CANTAB - Paired Associate Learning test (PAL)		24 weeks	No
Secondary	CANTAB - Verbal Recognition Memory (VRM)		24 weeks	No
Secondary	CANTAB - Spatial Span test (SSP)		24 weeks	No
Secondary	CANTAB - Reverse Spatial Span test (Reverse SSP)		24 weeks	No
Secondary	Wechsler Memory Scale - Logical memory subtest		24 weeks	No
Secondary	McNair scale		24 weeks	No
Secondary	Geriatric Depression Scale		24 weeks	No
Secondary	Mini-Mental State Examination		24 weeks	No
Secondary	Multidimensional Fatigue Inventory (MFI-20)		24 weeks	No

External Links

•   Click this link for more information about this study
•   Laboratoire NutriNeuro INRA-Université de Bordeaux