Effect of Polyphenol-rich Cocoa Products on Cognitive Function

Not Applicable

Completed

• Conditions: Healthy Ageing
• Interventions: Dietary Supplement: polyphenol rich chocolate bar; Dietary Supplement: low polyphenol content chocolate bar; Dietary Supplement: polyphenol rich cocoa powder; Dietary Supplement: low polyphenol content cocoa powder

• Registration Number: NCT02996578
• Lead Sponsor: Queen Margaret University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Study Start: 2017-04-17
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-26
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solid Matrix - Intervention	polyphenol rich chocolate bar	Dietary Supplement: polyphenol rich chocolate bar 17.5g of commercially available dark chocolate will be consumed daily for 8 weeks
Solid Matrix Intervention - Placebo	low polyphenol content chocolate bar	Dietary Supplement: low polyphenol chocolate 17.5g of commercially available, nutritionally similar, dark chocolate will be consumed daily for 8 weeks
Powder Matrix - Intervention	polyphenol rich cocoa powder	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
Powder Matrix - Placebo	low polyphenol content cocoa powder	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

Primary Outcome Measures

Name	Time	Method
Cognitive Function	8 weeks	A test battery consisting of 7 tests will be used to investigate the role of cocoa flavanols on cognitive function in the cohort.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Margaret University; 🇬🇧 Edinburgh, United Kingdom