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A study of the acute and chronic cognitive, neurocognitive and blood flow effects of polyphenols in middle aged volunteers.

A study of the acute and chronic cognitive, neurocognitive and blood flow effects of polyphenols in middle aged volunteers.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000879268
Enrollment
90
Registered
2009-10-09
Start date
2009-01-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The aim for the current trial is to understand how polyphenols affect cognition, brain functioning and blood flow for both acute and chronic doses. We wish to explore the acute (single dose) and four-week (28 doses) neuro-cognitive effects of polyphenols in 72 healthy middle aged volunteers. The cognitive effects will be assessed using the CDR computerised cognitive assessment system and the neurophysiological effects will be measured using high spatial resolution electrical brain recordings measures by the Steady State Topography technique (SST) which has been pioneered at the Brain Sciences Institute and used in over 50 published studies. The cardiovascular effects will be measured using Transcranail Doppler Ultrasound to measure blood flow and the sphygmocor system to measure arterial stiffness

Interventions

20 grams of dry blended chocolate drink mix will be administered in 200mL of water once daily for a total of 4 weeks. Participants will be allocated to receive one of the following treatments: - Treatment 1 - polyphenol-free dark chocolate containing <.5mg total flavanols - Treatment 2 - standard dark chocolate containing 200mg total flavanols - Treatment 3 - Acticoa dark chocolate containing 460mg total flavanols This is both an acute and chronic study. On the first testing day, participants w

20 grams of dry blended chocolate drink mix will be administered in 200mL of water once daily for a total of 4 weeks. Participants will be allocated to receive one of the following treatments: - Treatment 1 - polyphenol-free dark chocolate containing <.5mg total flavanols - Treatment 2 - standard dark chocolate containing 200mg total flavanols - Treatment 3 - Acticoa dark chocolate containing 460mg total flavanols This is both an acute and chronic study. On the first testing day, participants will undergo baseline testing and will then be administered one treatment. The acute effects will be tested 1 hour post dose. The chronic effects will be tested 4 weeks after consuming treatment once daily for 4 weeks. Participants will come for their testing session not having consumed their treatment for the day to measure the chronic effects. Baseline tests will reveal any chronic effects. Following this (on the same day), they will consume their last treatment and the acute/chronic effects will be measured.

Sponsors

Barry Callebaut
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

- non smoker - aged between 40 and 65 years - no history of anxiety, depression, psychiatric disorders or epilepsy - not taking any medication, herbal extracts, vitamin supplements or illicit drugs - no health conditions that would effect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g Irritable bowel syndrome, celiac disease, peptic ulcers) - not pregnant or breast feeding.

Exclusion criteria

- smoker - history of anxiety, depression, psychiatric disorders or epilepsy - taking any medication, herbal extracts, vitamin supplements or illicit drugs - health conditions that would effect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g Irritable bowel syndrome, peptic ulcers) - pregnant or breast feeding. - Free from epilepsy and have no history of epilepsy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026