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    Clinical trial on the effect of cocoa on cognitive function

    NIIM is conducting a clinical trial on the effect of cocoa on cognitive function in people aged 50 years or over.

    This study aims to investigate the acute effects of different doses of high-flavanol cocoa on cognitive function and mood. Cocoa flavanols have been associated with several health benefits including cardiovascular and cognitive functions and increase the formation of endothelial nitric oxide, responsible for the increased blood flow and improved cardiovascular and vascular function.

    Aim of Study:

    In this study, we want to find out:

    • To assess the acute effect and dose-response of high-flavanol cocoa tablets on cognitive function compared with placebo in middle aged adults
    • To assess the acute effect and dose-response of high-flavanol cocoa tablets on mood, fatigue and stress compared with placebo in middle aged adults

    Methodology:

    This study will examine participants’ cognitive function by a computerized test battery, measuring accuracy and speed of the response at baseline and 2 hours after ingestion of trial tablets containing either cocoa or placebo. A second dose of cocoa or placebo will be tested at 4 weeks.

    Am I eligible?

    In order to be eligible for participation you will have to meet our inclusion criteria. Are you?

    • Over 50 years of age
    • Have a good working knowledge of English
    • Not colour blind
    • Not currently suffering from medically diagnosed cardiovascular or cognitive impairment, psychiatric or neurological conditions
    • Not taking any cognitive enhancing medications or herbal supplements or illicit drugs
    • Not taking antidepressants, antipsychotics or anxiolytics
    • Not pregnant or lactating
    • Not participating in any other study

    What will I need to do?

    • Participants will be randomly allocated to either the cocoa or placebo group.
    • The two testing sessions will both take up to 4 hours.
    • After baseline testing (40 min) you will be given an allocated dose of trial tablets.
    • After a 2 hour break (fasting and no excessive movements), you will be doing another testing session (30 min).
    • Total time: <4 hours ( 2 hour break)

    Privacy and confidentiality

    Your personal data will be known only to the study team. All data collected will be de-identified before analysis and stored securely in locked files at the NIIM clinic. No personal data will be divulged in publication.

    Can I access test results?

    After the study when all data has been collected and analysed, you can receive a summary of the de-identified study results.

    Who should I contact if I want to take part, or have any questions about the study?

    Nikolaj (Nik) Travica
    Research Assistant
    National Institute of Integrative Medicine
    Hawthorn, VIC 3122
    Phone: 03 9912 9544
    Email: ntravica@niim.com.au

    Dr Karin Ried
    Research Director and Principal Investigator
    National Institute of Integrative Medicine
    Hawthorn, VIC 3122
    Phone: 03 9912 9545
    Email: karinried@niim.com.au

    If you wish to discuss with an independent person matters related to making a complaint, or your rights as a participant, contact the Human Research Ethics Committee’s Secretary on kbesim@niim.com.au.