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Completed

NCT Number: NCT02996578

Effect of Polyphenol-rich Cocoa Products on Cognitive Function

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.

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Key information

Conditions

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Margaret University

Edinburgh, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polyphenol rich chocolate bar

Dietary Supplement

High polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols

polyphenol rich cocoa powder

Dietary Supplement

High polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols

low polyphenol content chocolate bar

Dietary Supplement

Low polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols

low polyphenol content cocoa powder

Dietary Supplement

Low polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols

Primary outcomes

  1. Cognitive Function

    Time frame: 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 outcomes

  1. Blood Pressure

    Time frame: 8 weeks

  2. Pulse Wave Analysis

    Time frame: 8 weeks

    Carotid to femoral Pulse Wave Velocity (PWV) and Augmentation Index (Aix) will be measured using a Vicorder.

  3. Glycated Haemoglobin (HbA1c)

    Time frame: 8 weeks

  4. Weight (Kg)

    Time frame: 8 weeks

    To allow for BMI measurement

  5. Height (m)

    Time frame: 8 weeks

    To allow for BMI measurement

  6. Body Fat Percentage

    Time frame: 8 weeks

  7. Energy intakes (Kj)

    Time frame: 8 weeks

  8. Flavonoid intakes (mg)

    Time frame: 8 Weeks

Sponsors and collaborators

Lead sponsor

Queen Margaret University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2016
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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