Trial Review

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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.
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
Secondary ID [1] 282579 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 289264 0
Cardiovascular function 289265 0
Mood 289266 0
Condition category
Condition code
Neurological 289592 289592 0 0
Studies of the normal brain and nervous system
Cardiovascular 289593 289593 0 0
Normal development and function of the cardiovascular system
Mental Health 289594 289594 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287245 0
Treatment: Drugs
Comparator / control treatment
Placebo tablet
Control group
Placebo

Outcomes
Primary outcome [1] 289683 0
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
Timepoint [1] 289683 0
2 hours after ingestion of trial tablet compared with baseline
Primary outcome [2] 289684 0
Mood: Assessment by questionnaire
1. Visual Analog Mood Scale (Bond & Lander 1974)
2. State Trait Anxiety Inventory (Spielberger 1969)
Timepoint [2] 289684 0
2 hours after ingestion of trial tablet compared with baseline
Primary outcome [3] 289711 0
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)
Timepoint [3] 289711 0
4 weeks after baseline
Secondary outcome [1] 303006 0
Cardiovascular function:
1. Blood pressure using a Sphymomanometer
2. Arterial stiffness and central blood pressure using SphymoCor Tonometer
Timepoint [1] 303006 0
2 hours after ingestion of trial tablet compared with baseline
Secondary outcome [2] 303071 0
Cardiovascular function
1. Blood pressure using a Sphymomanometer
2. Arterial stiffness and central blood pressure using SphymoCor Tonometer
Timepoint [2] 303071 0
4 weeks after baseline

Eligibility
Key inclusion criteria
Healthy between 18-40 years of age
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/06/2013
Actual
19/08/2013
Date of last participant enrolment
Anticipated
31/10/2014
Actual
30/10/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6923 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 287367 0
University
Name [1] 287367 0
Participant vouchers:
Discipline of General Practice, The University of Adelaide
Country [1] 287367 0
Australia
Primary sponsor type
Other
Name
National Institute of Integrative Medicine
Address
759 Burwood Rd
Hawthorn East VIC 3123
Country
Australia
Secondary sponsor category [1] 286113 0
University
Name [1] 286113 0
Swinburne University of Technology
Address [1] 286113 0
Burwood Rd
Hawthorn VIC 3122
Country [1] 286113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289343 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 289343 0
Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 289343 0
Australia
Date submitted for ethics approval [1] 289343 0
26/03/2013
Approval date [1] 289343 0
26/04/2013
Ethics approval number [1] 289343 0
SUHREC 2013/058

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.
Trial website
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
Public notes

Contacts
Principal investigator
Name 40362 0
Dr Karin Ried
Address 40362 0
National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East VIC 3123
Country 40362 0
Australia
Phone 40362 0
+61 3 9804 0646
Fax 40362 0
Email 40362 0
[email protected]
Contact person for public queries
Name 40363 0
Karin Ried
Address 40363 0
National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East VIC 3123
Country 40363 0
Australia
Phone 40363 0
+61 3 9804 0646
Fax 40363 0
Email 40363 0
[email protected]
Contact person for scientific queries
Name 40364 0
Karin Ried
Address 40364 0
National Institute of Integrative Medicine
759 Burwood Rd
Hawthorn East VIC 3123
Country 40364 0
Australia
Phone 40364 0
+61 3 9804 0646
Fax 40364 0
Email 40364 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
SourceTitleYear of PublicationDOI
EmbaseThe acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: A randomized, controlled trial.2015https://dx.doi.org/10.3389/fphar.2015.00093
N.B. These documents automatically identified may not have been verified by the study sponsor.