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Effect of Polyphenol-rich Cocoa Products on Cognitive Function

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02996578
Enrollment
16
Registered
2016-12-19
Start date
2017-04-17
Completion date
2018-09-30
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Ageing

Keywords

Cognition, Cacao, Flavan-3-ols, Blood Pressure, hemoglobin A1c protein, human, Memory

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).

Interventions

DIETARY_SUPPLEMENTpolyphenol rich chocolate bar

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

DIETARY_SUPPLEMENTpolyphenol rich cocoa powder

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

DIETARY_SUPPLEMENTlow polyphenol content chocolate bar

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

DIETARY_SUPPLEMENTlow polyphenol content cocoa powder

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

Sponsors

Queen Margaret University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive Function8 weeksA test battery consisting of 7 tests will be used to investigate the role of cocoa flavanols on cognitive function in the cohort.

Secondary

MeasureTime frameDescription
Pulse Wave Analysis8 weeksCarotid to femoral Pulse Wave Velocity (PWV) and Augmentation Index (Aix) will be measured using a Vicorder.
Glycated Haemoglobin (HbA1c)8 weeks
Weight (Kg)8 weeksTo allow for BMI measurement
Blood Pressure8 weeks
Body Fat Percentage8 weeks
Energy intakes (Kj)8 weeks
Flavonoid intakes (mg)8 Weeks
Height (m)8 weeksTo allow for BMI measurement

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026