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

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ClinicalTrials.gov Identifier: NCT02063646
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Activ'inside
Atrium Innovations
Fruit d'Or
Laboratoire NutriNeuro Université de Bordeaux/INRA
NutraCanada
Laval University
Information provided by (Responsible Party):
Neurophenols Consortium

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.


Condition or disease Intervention/treatment Phase
Healthy Elderly Dietary Supplement: Polyphenol-rich extract Dietary Supplement: Placebo Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults: Randomized, Placebo-controlled, Double-blind Clinical Trial
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo

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

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.


Experimental: Polyphenol-rich extract

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
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.




Primary Outcome Measures :
  1. CANTAB - Paired Associate Learning test (PAL) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. CANTAB - Verbal Recognition Memory (VRM) [ Time Frame: 24 weeks ]
  2. CANTAB - Spatial Span test (SSP) [ Time Frame: 24 weeks ]
  3. CANTAB - Reverse Spatial Span test (Reverse SSP) [ Time Frame: 24 weeks ]
  4. Wechsler Memory Scale - Logical memory subtest [ Time Frame: 24 weeks ]
  5. McNair scale [ Time Frame: 24 weeks ]
  6. Geriatric Depression Scale [ Time Frame: 24 weeks ]
  7. Mini-Mental State Examination [ Time Frame: 24 weeks ]
  8. Multidimensional Fatigue Inventory (MFI-20) [ Time Frame: 24 weeks ]

Other Outcome Measures:
  1. Lipid profile [ Time Frame: 24 weeks ]
  2. Insulinemia and glycemia [ Time Frame: 24 weeks ]
  3. Inflammatory markers [ Time Frame: 24 weeks ]
  4. Hormones [ Time Frame: 24 weeks ]
  5. Urinary polyphenols [ Time Frame: 24 weeks ]
  6. Fatty acid profile in erythrocyte membranes [ Time Frame: 24 weeks ]
  7. Retinol Binding Protein and Transtyretin [ Time Frame: 24 weeks ]
  8. Nuclear receptor expression in mononuclear cells [ Time Frame: 24 weeks ]
  9. Gene expression in mononuclear cells by microarray approach [ Time Frame: 24 weeks ]
  10. Epigenetic markers [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063646


Locations
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Canada, Quebec
INAF (Institute of nutrition and functionnal foods)
Québec, Quebec, Canada, G1V 0A6
France
Biofortis
Saint-Herblain, France, 44800
Sponsors and Collaborators
Neurophenols Consortium
Activ'inside
Atrium Innovations
Fruit d'Or
Laboratoire NutriNeuro Université de Bordeaux/INRA
NutraCanada
Laval University
Investigators
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Principal Investigator: 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

Additional Information:
Publications:
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Responsible Party: Neurophenols Consortium
ClinicalTrials.gov Identifier: NCT02063646     History of Changes
Other Study ID Numbers: INAF-2012-242
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: October 2014

Keywords provided by Neurophenols Consortium:
polyphenols
memory
elderly