Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000990426
Ethics application status
Approved
Date submitted
20/07/2016
Date registered
27/07/2016
Date last updated
27/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vascular, cognitive and cerebrovascular function responses to acute consumption of chocolate in postmenopausal women
Scientific title
Vascular, cognitive and cerebrovascular function responses to acute consumption of chocolate in postmenopausal women
Secondary ID [1] 289722 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular function 299557 0
Cerebrovascular function 299558 0
Cognitive function 299559 0
Condition category
Condition code
Cardiovascular 299529 299529 0 0
Other cardiovascular diseases
Mental Health 299530 299530 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a counterbalanced within-subjects cross-over design, post-menopausal women will complete three experimental trials (plus an introductory session) at the School of Sport Science, Exercise and Health, The University of Western Australia. A washout period of one week will occur between each of the four sessions. Participants will be supervised for the duration of all sessions. They will be instructed to complete a food diary and abstain from caffeine, alcohol, chocolate and vigorous physical activity in the 24 h prior to the introductory session and to replicate this in the 24 h prior to each experimental session. At each session, participants will have 15min to consume one of the following energy-matched chocolate treatments (2099 kJ each); (a) 84 g of a high concentration cocoa (80%) ‘dark’ chocolate, (b) 87 g of a lower concentration cocoa (35%) ‘milk’ chocolate and (c) 85 g of a cocoa butter ‘white’ chocolate (0% cocoa solids). Measures of cerebral blood flow velocity responses, recorded before and during completion of a computerised cognitive assessment battery (CogState), brachial artery flow-mediated dilation (FMD) and hemodynamic responses (heart rate, blood pressure) will be obtained in response to chocolate consumption. Each session will be approximately 2 hours in duration.
Intervention code [1] 295358 0
Lifestyle
Comparator / control treatment
The three chocolate conditions will be isocaloric, but contain varied polyphenol content to assess a dose response (80% cocoa 'dark' chocolate (395 mg polyphenols), a 35% cocoa 'milk' chocolate (200 mg polyphenols) and a cocoa butter 'white' chocolate (35 mg polyphenols).
Control group
Dose comparison

Outcomes
Primary outcome [1] 299009 0
Neurovascular reactivity: Assessment of cerebral blood flow responses to chocolate ingestion during simultaneous manipulation of cerebral metabolism (change in cognitive demand).

Cerebral blood flow response: Continuous cerebral blood flow velocity (CBFv) of bilateral middle cerebral arteries will be assessed via transcranial Doppler. Participants will be instrumented with a headframe (Marc 600, Spencer Technologies) capable of bilaterally transfixing two 2-MHz ultrasound probes over the temporal window. Measurements will obtained and exported in real time to a data acquisition system (PowerLab, LabChart 7; ADInstruments, Sydney, Australia) for post hoc analysis.

Cognitive demand: Participants will complete a computer-based cognitive battery (CogState Research TM), a widely used and accepted academic research tool. For the measurement of neurovascular reactivity, This CogState task is used as a tool to stimulate changes in cerebral metabolism which in turn can influence CBFv. this corresponding change in CBFv is what is being assessed. Further details of the CogState test are detailed below in secondary outcomes.
Timepoint [1] 299009 0
During the familiarisation session and 60mins post-chocolate consumption of white, milk and dark chocolate on experimental trial days.
Primary outcome [2] 299010 0
Vascular endothelial function: Assessed via flow-mediated dilation which is a non-invasive high-resolution ultrasound (Terason, t3200, Burlington, MA 01803, USA) imaging technique of the brachial artery which will be performed on the non-dominant arm. Images will be optimised and recordings taken during a 1 minute resting baseline which will be follwoed by the inflation of an occlussion cuff for 5 min to 220 mmHg around the forearm. Scanning will be continued following deflation of the cuff for 3 min. Continuous (30 Hz) brachial lumen cross-sectional area and Doppler velocity will be used to calculate brachial blood flow and shear stress, along with changes in arterial diameter. FMD will be calculated in absolute (mm) and relative (%) terms as the increase from the 1 min resting baseline diameter.
Timepoint [2] 299010 0
Vascular endothelial function will be assessed at baseline (pre-chocolate) and 80 min following chocolate consumption.
Primary outcome [3] 299011 0
Resting cerebrovascular perfusion: Resting cerebral blood flow velocity (CBFv) of bilateral middle cerebral arteries will be assessed via transcranial Doppler. Participants will be instrumented with a headframe (Marc 600, Spencer Technologies) capable of bilaterally transfixing two 2-MHz ultrasound probes over the temporal window. Measurements will obtained and exported in real time to a data acquisition system (PowerLab, LabChart 7; ADInstruments, Sydney, Australia) for post hoc analysis.
Timepoint [3] 299011 0
Resting CBFv will be obtained for 5 min in a rested state in a standardised room devoid of stimulation. Participants will be seated in front of a blank whiteboard and told to focus on the screen. Measurements will obtained in this way during the familiarisation session, and prior to, and 60 min after chocolate consumption on each experimental session. .
Secondary outcome [1] 325860 0
Cognitive function will be assessed using a computer-based cognitive battery (CogState Research TM), a widely used and accepted academic research tool. A laptop will be placed in front of the participants and they will be instructed to complete the battery of tests as accurately as possible. The battery requires approximately 20 min to complete and consists of 7 distinct tasks that will be presented in the same order.
Timepoint [1] 325860 0
During the familiarisation session and 60mins post-chocolate consumption of white, milk and dark chocolate on experimental trial days.
Secondary outcome [2] 325861 0
Hemodynamics: Beat-to-beat continuous heart rate, stroke volume and blood pressure (mean arterial pressure) will be recorded using a Finometer PRO (Finapres Medical Systems, Amsterdam). Briefly, this involves a finger cuff placed around the middle finger of the participants non-dominant arm, which will be supported and remain stationary at the level of the right atrium on a platform. Vigilant supervision during recording will ensure this is the case. Measurements will obtained and exported in real time to a data acquisition system (PowerLab, LabChart 7; ADInstruments, Sydney, Australia) for post hoc analysis.
Timepoint [2] 325861 0
Recorded continuously during the the assessments of resting cerebrovascular perfusion (during the familiarisation session, and prior to and 60min after chocolate consumption during each experimental session) and neurovascular reactivity (during the familiarisation session and 60min post-chocolate consumption during each experimental session). .

Eligibility
Key inclusion criteria
Healthy, postmenopausal women aged 50-65 yr. They must like eating all types of chocolate (white, milk, dark).
Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who are taking any prescribed medication, have any known cardiovascular related diseases or smokers.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Within-subject, counterbalanced design
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
1/08/2015
Date of last data collection
Anticipated
Actual
15/04/2016
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 13648 0
6009 - Crawley

Funding & Sponsors
Funding source category [1] 294101 0
University
Name [1] 294101 0
The University of Western Australia
Country [1] 294101 0
Australia
Primary sponsor type
University
Name
The University of Western Australia, School of Sports Science, Exercise and Health
Address
The University of Western Australia, School of Sport Science, Exercise and Health, 35 Stirling Highway, Crawley, WA, Australia, 6009
Country
Australia
Secondary sponsor category [1] 292937 0
None
Name [1] 292937 0
Address [1] 292937 0
Country [1] 292937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295516 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 295516 0
Ethics committee country [1] 295516 0
Australia
Date submitted for ethics approval [1] 295516 0
20/01/2015
Approval date [1] 295516 0
20/02/2015
Ethics approval number [1] 295516 0
RA/4/1/7321

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

Contacts
Principal investigator
Name 67582 0
Miss Channa Marsh
Address 67582 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, Australia, 6009
Country 67582 0
Australia
Phone 67582 0
(+61 8) 6488 2361
Fax 67582 0
Email 67582 0
[email protected]
Contact person for public queries
Name 67583 0
Channa Marsh
Address 67583 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, Australia, 6009
Country 67583 0
Australia
Phone 67583 0
(+61 8) 6488 2361
Fax 67583 0
Email 67583 0
[email protected]
Contact person for scientific queries
Name 67584 0
Channa Marsh
Address 67584 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, Australia, 6009
Country 67584 0
Australia
Phone 67584 0
(+61 8) 6488 2361
Fax 67584 0
Email 67584 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
EmbaseBrachial and cerebrovascular functions are enhanced in postmenopausal women after ingestion of chocolate with a high concentration of cocoa.2017https://dx.doi.org/10.3945/jn.117.250225
N.B. These documents automatically identified may not have been verified by the study sponsor.