Effect of Polyphenol-rich Cocoa Products on Cognitive Function

Study Overview
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Brief Summary
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This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing.

Detailed Description
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Healthy cognitive ageing is an important aspect of the ageing process as it involves larger numbers of people compared to those who have already been diagnosed with conditions on the dementia spectrum (Deary et al, 2009). Hence, an active effort looking at potential lifestyle factor modification interventions to help maintain cognitive well-being are warranted. With an ageing population, the prevalence of cognitive syndromes such as Alzheimer's disease and Parkinson's disease increases (Vauzour, 2012). Nutritional interventions can play a role in successful ageing by helping to delay the onset of age-related conditions (Hendrickx, McEwen & van der Ouderaa, 2005; Brown, Riby & Reay, 2009; Monti, Moulton & Cohen, 2015). Studies have investigated the potential role of polyphenols as part of a neuroprotective lifestyle. Mouse model studies have looked at varying polyphenol sources such as tea (Haque et al., 2006; Kaur et al., 2008), blueberry (Shukitt-Hale et al., 2015; Williams et al., 2008), Gingko Biloba (Shif et al., 2008) and cocoa (Bisson et al., 2008) to mention a few. Ageing and neurodegenerative diseases are caused by neuronal death which in turn can be triggered by neurotoxins, neuroinflammation and specific genetic mutations (Bishop, Lu & Yankner, 2010). Dietary polyphenols have been observed to provide neuroprotection against cellular alteration by modulating the neuronal function against endogenous neurotoxins and inhibition of glial induced neuroinflammation (Vauzour, 2012).

Official Title
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Consumption of Polyphenol Rich Cocoa Products Over 8 Weeks and Its Effect on Cognitive Function in Individuals in Their 5th Decade of Life.

Conditions
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Healthy Ageing

Intervention / Treatment
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* Dietary Supplement: polyphenol rich chocolate bar
* Dietary Supplement: polyphenol rich cocoa powder
* Dietary Supplement: low polyphenol content chocolate bar
* Dietary Supplement: low polyphenol content cocoa powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males & Females aged 50-60years of age with normal or corrected to normal vision BMI cut off points of ≥18.5 to ≤29.9 kg/m2 Waist circumference smaller than 102cm for males & smaller than 88cm for women Blood pressure of ≥ 90 over 60 and ≤ 120 over 80 MoCA test score ≥ 26 Exclusion Criteria: Allergies to cocoa or any other ingredients commonly found in cocoa confectionary eg: milk, nuts, soya Smoker Women who are new or expecting mothers, maybe or are currently pregnant and/or breastfeeding Taking medications for chronic conditions including (but not limited to) diabetes, heart disease, hypertension No previous history of stroke, brain trauma and other head-related injuries No diagnosis of depression and/or anxiety No previous cancer diagnosis Taking antibiotics Taking steroids and non-steroidal anti-inflammatory drugs (NSAIDS) Women on Hormone Replacement Therapy (HRT) Taking medication that can cause drowsiness or affect cognitive functioning Taking polyphenol supplements including (but not limited to) green tea extract, acai berry extract Taking soy/a supplements History of alcohol misuse Fear of needles and/or fainting when blood is taken

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Solid Matrix - Intervention<br>Dietary Supplement: polyphenol rich chocolate bar 17.5g of commercially available dark chocolate will be consumed daily for 8 weeks | Dietary Supplement: polyphenol rich chocolate bar<br>* High polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols<br>|
| Active Comparator: Powder Matrix - Intervention<br>Dietary Supplement: polyphenol rich cocoa powder 6g of commercially available cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks | Dietary Supplement: polyphenol rich cocoa powder<br>* High polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols<br>|
| Placebo Comparator: Solid Matrix Intervention - Placebo<br>Dietary Supplement: low polyphenol chocolate 17.5g of commercially available, nutritionally similar, dark chocolate will be consumed daily for 8 weeks | Dietary Supplement: low polyphenol content chocolate bar<br>* Low polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols<br>|
| Placebo Comparator: Powder Matrix - Placebo<br>Dietary Supplement: nutritionally similar low polyphenol cocoa powder 6g of commercially available, nutritionally similar, cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks | Dietary Supplement: low polyphenol content cocoa powder<br>* Low polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function | A test battery consisting of 7 tests will be used to investigate the role of cocoa flavanols on cognitive function in the cohort. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 8 weeks | 
| Pulse Wave Analysis | Carotid to femoral Pulse Wave Velocity (PWV) and Augmentation Index (Aix) will be measured using a Vicorder. | 8 weeks | 
| Glycated Haemoglobin (HbA1c) |  | 8 weeks | 
| Weight (Kg) | To allow for BMI measurement | 8 weeks | 
| Height (m) | To allow for BMI measurement | 8 weeks | 
| Body Fat Percentage |  | 8 weeks | 
| Energy intakes (Kj) |  | 8 weeks | 
| Flavonoid intakes (mg) |  | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Cacao, Flavan-3-ols, Blood Pressure, hemoglobin A1c protein, human, Memory