Effect of Polyphenol-rich Cocoa Products on Cognitive Function

Sponsor

Queen Margaret University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02996578

Collaborator

(none)

128

Enrollment

Location

Arms

33.5

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Ageing	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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 17, 2017

Actual Primary Completion Date :

Sep 30, 2018

Anticipated Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Solid Matrix - Intervention 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 High polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols
Active Comparator: Powder Matrix - Intervention 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 High polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols
Placebo Comparator: Solid Matrix Intervention - Placebo 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 Low polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols
Placebo Comparator: Powder Matrix - Placebo 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 Low polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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