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Trial registered on ANZCTR
Registration number
ACTRN12613000626763
Ethics application status
Approved
Date submitted
28/05/2013
Date registered
31/05/2013
Date last updated
8/02/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Cocoa for cognitive function, mood and cardiovascular function: acute and cumulative effect in younger adults.
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Scientific title
The acute and cumulative effect of high-flavanol cocoa vs placebo on cognitive function, mood and cardiovascular function in healthy adults aged 18-40 years: a randomised double-blind placebo-controlled one month trial
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Secondary ID [1]
282579
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cognitive function
289264
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Cardiovascular function
289265
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Mood
289266
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Condition category
Condition code
Neurological
289592
289592
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0
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Studies of the normal brain and nervous system
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Cardiovascular
289593
289593
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0
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Normal development and function of the cardiovascular system
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Mental Health
289594
289594
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will take one tablet of a cocoa supplement (containing 250 mg polyphenols) after baseline assessment & assessment 2 hours after ingestion (acute) and one tablet of cocoa supplement daily for 4 weeks (cumulative).
Calendars including trial information will be provided to patients at baseline. To assess compliance, patients will be instructed to mark each day when they have taken the trial capsules, and bring the calendar and any remaining trial capsules to their next appointment.
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Intervention code [1]
287245
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Treatment: Drugs
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Comparator / control treatment
Placebo tablet
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Control group
Placebo
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Outcomes
Primary outcome [1]
289683
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Cognitive function:
1. By computerised standardised validated assessement battery: SUCCAB (Swinburne University Computerised Cognitive Ageing Battery) containing 7 tasks (e.g. simple reaction time, spatial working memory), and takes about 25 minutes
2. Cognitive Demand Battery: Consists of two computerised serial subtraction tasks (serial threes and serial sevens) and takes about 10 minutes
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Assessment method [1]
289683
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Timepoint [1]
289683
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2 hours after ingestion of trial tablet compared with baseline
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Primary outcome [2]
289684
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Mood: Assessment by questionnaire
1. Visual Analog Mood Scale (Bond & Lander 1974)
2. State Trait Anxiety Inventory (Spielberger 1969)
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Assessment method [2]
289684
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Timepoint [2]
289684
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2 hours after ingestion of trial tablet compared with baseline
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Primary outcome [3]
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Cognitive function
1. By computerised standardised validated assessement battery: SUCCAB (Swinburne University Computerised Cognitive Ageing Battery) containing 7 tasks (e.g. simple reaction time, spatial working memory), and takes about 25 minutes
2. Cognitive Demand Battery: Consists of two computerised serial subtraction tasks (serial threes and serial sevens) and takes about 10 minutes
Mood
1. Visual Analog Mood Scale (Bond & Lander 1974)
2. State Trait Anxiety Inventory (Spielberger 1969)
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Assessment method [3]
289711
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Timepoint [3]
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4 weeks after baseline
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Secondary outcome [1]
303006
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Cardiovascular function:
1. Blood pressure using a Sphymomanometer
2. Arterial stiffness and central blood pressure using SphymoCor Tonometer
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Assessment method [1]
303006
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Timepoint [1]
303006
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2 hours after ingestion of trial tablet compared with baseline
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Secondary outcome [2]
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Cardiovascular function
1. Blood pressure using a Sphymomanometer
2. Arterial stiffness and central blood pressure using SphymoCor Tonometer
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Assessment method [2]
303071
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Timepoint [2]
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4 weeks after baseline
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Eligibility
Key inclusion criteria
Healthy between 18-40 years of age
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Poor comprehension of written and spoken English
2. Psychiatric disorder
3. Suffering from endocrine or gastrointestinal disorders
4. Pregnant or lactating
5. Taking antidepressants, antipsychotics, anxiolytics, illicit drugs or any cognitive enhancing drugs
6. Undergoing participation in another study
7. Suffer from colour blindness or any other severe visual impairment
8. Taking anti-coagulants or have bleeding disorders
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting volunteers will be allocated to either cocoa or placebo tablets. Cocoa and placebo tablets are matched in size and appearance and are packaged in identical containers labelled with the ID and study identifier.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated permuted block randomisation schedule will be used to allocate patients to cocoa or placebo-control groups. Randomisation will be done by a statistical consultant not involved in allocation of treatment to the participants.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A sample size of 40 participants (20 in each group) is calculated based on the following assumptions:
a) To detect a difference of 12 +/- 3 mm on the VAS Mental fatigue scale as part of the Cognitive Demand Battery after 10 min of consuming an acute dose of a cocoa product containing 520 mg of cocoa flavanols had 30 participants in a three week period crossover design (scholey 2010) with a power of 80% and 95% confidence
b) To account for 20% drop-out or non-attendance at all appointments
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
17/06/2013
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Actual
19/08/2013
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Date of last participant enrolment
Anticipated
31/10/2014
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Actual
30/10/2015
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
6923
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3122 - Hawthorn
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Funding & Sponsors
Funding source category [1]
287367
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University
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Name [1]
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Participant vouchers:
Discipline of General Practice, The University of Adelaide
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Address [1]
287367
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Level 11, 178 North Tce
Adelaide, SA 5005
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Country [1]
287367
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Australia
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Primary sponsor type
Other
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Name
National Institute of Integrative Medicine
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Address
759 Burwood Rd
Hawthorn East VIC 3123
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Country
Australia
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Secondary sponsor category [1]
286113
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University
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Name [1]
286113
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Swinburne University of Technology
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Address [1]
286113
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Burwood Rd
Hawthorn VIC 3122
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Country [1]
286113
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289343
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Swinburne University Human Research Ethics Committee
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Ethics committee address [1]
289343
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Burwood Rd
Hawthorn VIC 3122
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Ethics committee country [1]
289343
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Australia
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Date submitted for ethics approval [1]
289343
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26/03/2013
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Approval date [1]
289343
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26/04/2013
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Ethics approval number [1]
289343
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SUHREC 2013/058
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Summary
Brief summary
Study aims to investigate the effects of acute and cumulative doses of high-flavanol cocoa on cognitive function, mood, and cardiovascular health in a group of healthy younger adults.
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Trial website
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Trial related presentations / publications
Massee LA, Ried K, Pase M et al. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: and RCT. Frontiers in Pharmacology 2015, 6: 93
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Public notes
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Contacts
Principal investigator
Name
40362
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Dr Karin Ried
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Address
40362
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National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East VIC 3123
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Country
40362
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Australia
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Phone
40362
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+61 3 9804 0646
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Fax
40362
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Email
40362
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[email protected]
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Contact person for public queries
Name
40363
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Dr Karin Ried
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Address
40363
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National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East VIC 3123
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Country
40363
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Australia
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Phone
40363
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+61 3 9804 0646
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Fax
40363
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Email
40363
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[email protected]
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Contact person for scientific queries
Name
40364
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Dr Karin Ried
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Address
40364
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National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East VIC 3123
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Country
40364
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Australia
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Phone
40364
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+61 3 9804 0646
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Fax
40364
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Email
40364
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: A randomized, controlled trial.
2015
https://dx.doi.org/10.3389/fphar.2015.00093
N.B. These documents automatically identified may not have been verified by the study sponsor.
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