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Effect of Polyphenol-rich Cocoa Products on Cognitive Function

Q

Queen Margaret University

Status

Completed

Conditions

Healthy Ageing

Treatments

Dietary Supplement: low polyphenol content chocolate bar
Dietary Supplement: polyphenol rich cocoa powder
Dietary Supplement: polyphenol rich chocolate bar
Dietary Supplement: low polyphenol content cocoa powder

Study type

Interventional

Funder types

Other

Identifiers

NCT02996578
QueenMUra

Details and patient eligibility

About

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.

Full 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).

Enrollment

16 patients

Sex

All

Ages

50 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 4 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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