Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults
Condition: Healthy Elderly
Study type: Interventional

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).
    

Intervention name(s): Polyphenol-rich extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: polyphenols; memory; elderly