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

NCT02063646 | Completed

• 1 other identifier: INAF-2012-242
• Study Type: interventional
• Target: 204
• Locations: 2 countries
• Sites: 2

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.

Conditions

Healthy Elderly

Keywords

polyphenols; memory; elderly

Outcome Measures

Primary Outcomes (1)

• CANTAB - Paired Associate Learning test (PAL)

  24 weeks

Secondary Outcomes (8)

• CANTAB - Verbal Recognition Memory (VRM)

  24 weeks

• CANTAB - Spatial Span test (SSP)

  24 weeks

• CANTAB - Reverse Spatial Span test (Reverse SSP)

  24 weeks

• Wechsler Memory Scale - Logical memory subtest

  24 weeks

• McNair scale

  24 weeks

Other Outcomes (10)

• Lipid profile

  24 weeks

• Insulinemia and glycemia

  24 weeks

• Inflammatory markers

  24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component. Dose: 2 capsules per day, one capsule at least 1 hour after breakfast and one capsule at least one hour after dinner, with a glass of water.

Dietary Supplement: Placebo

Polyphenol-rich extract

EXPERIMENTAL

The test product is a food supplement named Neurophenol. It is presented as a hard-shell capsule containing polyphenol-rich extracts. Dose: 2 capsules per day, one capsule at least 1 hour after breakfast and one capsule at least one hour after dinner, with a glass of water.

Dietary Supplement: Polyphenol-rich extract

Interventions

Polyphenol-rich extract DIETARY_SUPPLEMENT

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.

Polyphenol-rich extract

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Independent subjects, living at home;
• Body Mass Index (BMI) 20-30 kg/m2 (limits included);
• \< 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Neurophenols Consortium: lead
• Activ'inside: collaborator
• Atrium Innovations: collaborator
• Fruit d'Or: collaborator
• Laboratoire NutriNeuro Université de Bordeaux/INRA: collaborator
• NutraCanada: collaborator
• Laval University: collaborator

Study Sites (2)

INAF (Institute of nutrition and functionnal foods)

Québec, Quebec, G1V 0A6, Canada

Location

Biofortis

Saint-Herblain, 44800, France

Location

Related Publications (5)

• 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.

  PMID: 22468945 BACKGROUND

• 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.

  PMID: 22090468 BACKGROUND

• 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.

  PMID: 18415677 BACKGROUND

• 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.

  PMID: 19822127 BACKGROUND

• 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.

  PMID: 18937002 BACKGROUND

Related Links

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

Study Officials

• Carol Hudon, Ph.D.

  Laval University

  PRINCIPAL INVESTIGATOR

• Véronique Pallet, Ph.D.

  Laboratoire NutriNeuro Université de Bordeaux/INRA

  PRINCIPAL INVESTIGATOR

• Catherine Bégin, Ph.D.

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2014-10

Locations

CA (1); FR (1)