Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000879268
Ethics application status
Approved
Date submitted
28/09/2009
Date registered
9/10/2009
Date last updated
9/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the acute and chronic cognitive, neurocognitive and blood flow effects of polyphenols in middle aged volunteers.
Scientific title
A study of the acute and chronic cognitive, neurocognitive and blood flow effects of polyphenols in middle aged volunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 251928 0
Cardiovascular function 251929 0
Neuro-cognitive function 251931 0
Condition category
Condition code
Alternative and Complementary Medicine 252112 252112 0 0
Other alternative and complementary medicine
Cardiovascular 252113 252113 0 0
Normal development and function of the cardiovascular system
Mental Health 252114 252114 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241350 0
Lifestyle
Intervention code [2] 241351 0
Behaviour
Comparator / control treatment
- Treatment 1 - polyphenol-free dark chocolate
Control group
Active

Outcomes
Primary outcome [1] 252993 0
Cognitive performance measured using Cognitive Drug Research (CDR) computerised cognitive battery
Timepoint [1] 252993 0
ACUTE: 1 hour, 2.5 hours and 4 hours post dose

CHRONIC: 4 weeks after consuming chocolate treatment each day for 4 weeks

CHRONIC/ACUTE: 1 hour, 2.5 hours and 4 hours post dose on second visit (4 weeks after consumption)
Primary outcome [2] 252994 0
Cardiovascular function measured using Transcranial Doppler (TCD) ultrasound to measure blood flow in the middle cerebral artery and common corotid artery and the Sphygmocor (arterial stiffness) system
Timepoint [2] 252994 0
ACUTE: 2 hours post dose
CHRONIC: 4 weeks after consuming chocolate treatment each day for 4 weeks
CHRONIC/ACUTE: 2 hours post dose on second visit (4 weeks after consumption)
Secondary outcome [1] 257760 0
Neuro-cognitive performance using Steady State Topography (SST)
Timepoint [1] 257760 0
CHRONIC: 4 weeks (after consuming chocolate treatment each day for 4 weeks)

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants responded to ads via community bulletin boards and local papers. Once they passed a phone screen, they came in for a practice session where they were introduced to the tests and informed consent was obtained. They were randomly allocated to a treatment group. The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party generated the randomisation list using a computerised random number sequence generator. Participants were allocated to receive 1 of 3 treatments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
a randomized, double-blind, placebo-controlled, within-subjects design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243808 0
Commercial sector/Industry
Name [1] 243808 0
Barry Callebaut
Country [1] 243808 0
Belgium
Primary sponsor type
Commercial sector/Industry
Name
Barry Callebaut
Address
Aalstersestraat 122
B-9280 Lebbeke
Country
Belgium
Secondary sponsor category [1] 237160 0
None
Name [1] 237160 0
Address [1] 237160 0
Country [1] 237160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243938 0
Swinburne Univeristy Human Research Ethics Committee
Ethics committee address [1] 243938 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 243938 0
Australia
Date submitted for ethics approval [1] 243938 0
Approval date [1] 243938 0
Ethics approval number [1] 243938 0
0708/156

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30336 0
Address 30336 0
Country 30336 0
Phone 30336 0
Fax 30336 0
Email 30336 0
Contact person for public queries
Name 13583 0
Prof Con Stough
Address 13583 0
400 Burwood Rd
Hawthorn VIC 3122
Country 13583 0
Australia
Phone 13583 0
613 9214 8167
Fax 13583 0
Email 13583 0
[email protected]
Contact person for scientific queries
Name 4511 0
Prof Con Stough
Address 4511 0
400 Burwood Rd
Hawthorn VIC 3122
Country 4511 0
Australia
Phone 4511 0
613 9214 8167
Fax 4511 0
Email 4511 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.