Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000255583
Ethics application status
Approved
Date submitted
2/03/2015
Date registered
19/03/2015
Date last updated
8/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cocoa on cognitive function
Scientific title
The acute effect and dose-response of a high-flavanol cocoa product on cognitive function and mood in middle aged adults
Secondary ID [1] 286292 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 294376 0
Mental fatigue 294474 0
Condition category
Condition code
Neurological 294694 294694 0 0
Studies of the normal brain and nervous system
Mental Health 294780 294780 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 294781 294781 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised double-blind placebo-controlled trial will test the acute effect and dose-response of 2 doses of cocoa (Dose 1: 2 tablets: 6116 mg Theobroma cacao seed extract standardised to 500 mg catechins polyphenols and 11.12 mg theobromine; Dose 2: 4 tablets containing 1g of catechins polyphenols and 22.24 mg theobromine) compared to flavanols-free placebo on cognition using the computerised SUCCAB test battery in a middle aged population in the NIIM cognitive function lab. On Day 1, after baseline assessment cocoa or placebo tablets will be given to participants, and cognition will be tested on 2 hours after ingestion of the trial tablets. Cognitive assessment will be repeated 4 weeks later on the same participants using a different dose of cocoa.
Intervention code [1] 291329 0
Treatment: Other
Comparator / control treatment
Placebo: flavanol-free cellulose-silica tablet
Control group
Placebo

Outcomes
Primary outcome [1] 294454 0
cognitive function using the computerised validated SUCCAB test battery (Swinburne University Computerised Cognitive Assessment Battery)
Timepoint [1] 294454 0
2 hours after intervention
Secondary outcome [1] 313359 0
Composite: mood and mental fatigue using the validated Spielberger State Anxiety Trait Inventory and the the Bond-Lader Visual Analogue Mood Scale
Timepoint [1] 313359 0
2 hours after intervention

Eligibility
Key inclusion criteria
- Adults 40-70 years
- Have a good working knowledge of English
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Colour blind
- Currently suffering from medically diagnosed cardiovascular or cognitive impairment, psychiatric or neurological conditions
- Taking any cognitive enhancing medications or herbal supplements or illicit drugs
- Taking antidepressants, antipsychotics or anxiolytics
- Taking anti-coagulants or have bleeding disorders
- Pregnant or lactating
- Participating in any other study

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)
Recruitment: In the first instance we will contact past trial participants, who agreed to be contacted again to be invited to participate in a trial at NIIM. In addition, we will distribute flyers in letterboxes in the local area, as this recruitment strategy has worked well in the last trial (30% of participants had been recruited through letterbox drop).
Allocation: Cocoa tablets and placebo tablets will be matched in colour, size, and number (Dose 1 = 2 tablets; Dose 2 = 4 tablets), and packaged in identical containers labelled consecutively.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisations will be conducted using a computer-generated random number table by an independent researcher not involved in data collection. We will undertake two randomisations: Randomisation 1: Participants will be randomly allocated to either dose 1 or placebo on day 1; Randomisation 2: Participants will be randomly allocated to either dose 2 or placebo on day 28
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
Other
Other design features
Parallel design in part 1 (randomisation 1, dose 1 on day 1);
parallel design in part 2 (randomisation 2, dose 2, on day 28) with same participants as in part 1
Two time points will be analysed independently
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome will be cognitive function in accuracy and speed using the SUCCAB test battery (30 minutes) at 2 hours after ingestion of cocoa tablets (Dose 1) or placebo on Day 1, and at 4 weeks ingestion of cocoa tablets (Dose 2) compared to baseline. Cocoa tablets will be analysed for flavanols and theobromine content.
Secondary outcome will be assessment of mood, mental fatigue, and stress using the Bond-Lader Visual Analogue Mood Scale and the Spielberger State Anxiety Trait Inventory (STAIT) before and after each testing session.
All comparisons will be made using ANOVA and t-tests.

A sample size of 40 participants (20 in each group in part 1 and in part 2) was calculated based on the following assumptions:
a) To detect a difference of 57 ± 90 msec in the working memory reaction time test of the SUCCAB test battery with a power of 80% and 95% confidence (Macpherson H et al Psychopharmacology 2012, 220: 351-365)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2015
Actual
7/08/2015
Date of last participant enrolment
Anticipated
30/10/2015
Actual
7/12/2015
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] 9325 0
3122 - Hawthorn West

Funding & Sponsors
Funding source category [1] 290858 0
Self funded/Unfunded
Name [1] 290858 0
Country [1] 290858 0
Primary sponsor type
Charities/Societies/Foundations
Name
National Institute of Integrative Medicine
Address
21 Burwood Rd, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 289550 0
None
Name [1] 289550 0
Address [1] 289550 0
Country [1] 289550 0
Other collaborator category [1] 278377 0
Individual
Name [1] 278377 0
A/Prof Andrew Pipingas
Address [1] 278377 0
Centre for Human Psychopharmacology
Swinburne University
PO Box 218
Hawthorn, VIC 3122
Country [1] 278377 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292474 0
NIIM HREC
Ethics committee address [1] 292474 0
Ethics committee country [1] 292474 0
Australia
Date submitted for ethics approval [1] 292474 0
Approval date [1] 292474 0
16/02/2015
Ethics approval number [1] 292474 0
0021N-2015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55454 0
Dr Karin Ried
Address 55454 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Country 55454 0
Australia
Phone 55454 0
+61 3 9912 9545
Fax 55454 0
Email 55454 0
[email protected]
Contact person for public queries
Name 55455 0
Karin Ried
Address 55455 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Country 55455 0
Australia
Phone 55455 0
+61 3 9912 9545
Fax 55455 0
Email 55455 0
[email protected]
Contact person for scientific queries
Name 55456 0
Karin Ried
Address 55456 0
National Institute of Integrative Medicine
21 Burwood Rd, Hawthorn, VIC 3122
Country 55456 0
Australia
Phone 55456 0
+61 3 9912 9545
Fax 55456 0
Email 55456 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.