Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000067976
Ethics application status
Approved
Date submitted
18/01/2011
Date registered
19/01/2011
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acute effects of coffee extract on cognitive function and mood in healthy older adults
Scientific title
The acute effects of coffee extract on cognitive function and mood in healthy older adults
Secondary ID [1] 253286 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 258813 0
Cerebral Blood Flow 258814 0
Condition category
Condition code
Diet and Nutrition 258962 258962 0 0
Other diet and nutrition disorders
Mental Health 259128 259128 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants each consume one dose of each of the 3 treatments: coffee (6g), coffee extract (540mg), placebo at least 1 week apart.
All treatments are powder form and mixed with water (with milk/saccharin as desired)
Intervention code [1] 257739 0
Behaviour
Comparator / control treatment
Placebo (microcellulose), identical to the active treatments
Control group
Placebo

Outcomes
Primary outcome [1] 259815 0
Rapid visual information processing task (accuracy) - measure of sustained attention.
Timepoint [1] 259815 0
Baseline, 40mins and 120mins post dose
Secondary outcome [1] 268618 0
Other cognitive tasks:
- Rapid visual information processing task (as above) - reaction time and false alarm rate
- Inspection Time task - measure of visual information processing speed
- Serial sevens - measure of concentration and working memory
- Serial Threes - measure of concentration and working memory
- Jenson Box reaction time task - measure of reaction time performance whereby decision time and movement time are separated
- N-back task - measure of sustained and selective attention and impulsivity
- Emotional face recognition task - measure of emotional processing and attention
Timepoint [1] 268618 0
Baseline, 40mins and 120mins post dose
Secondary outcome [2] 268619 0
Mood questionnaires:
- Bond & Lader Visual Analogue Scales (Bond & Lader, 1974) - subjective measure of mood and alertness
- Caffeine Research Visual Analogue Scales - subjective assessment of feelings of "relaxed", "alert", "jittery", "tired", "tense", "headache", overall mood", and "mental fatigue".
Timepoint [2] 268619 0
Once before and once after all the cognitive tests (baseline, 40mins and 120mins post dose)
Secondary outcome [3] 268620 0
Cerebral Blood flow (using transcranial doppler ultrasound)
Timepoint [3] 268620 0
Baseline, 90mins post dose

Eligibility
Key inclusion criteria
*Age 50 and over
*Healthy (i.e. absence of all exclusion criteria) older male and female adults
*Light to moderate coffee drinkers (i.e. with caffeine)
*Drink no more than 8 cups of coffee per week
*Participants must abstain from caffeine-containing foods/beverages and alcohol for 24 hours prior to the training session and each testing session.
*Written informed consent obtained
Minimum age
50 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Existing or pre-existing physical or neurological conditions
*History of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
*Clinically high blood pressure
*Under treatment with spironolactone-like anti-diuretics, aldosteron-receptors antagonists or angiotensin II- antagonists
*Hearing impairment
*Psychoactive medications
*History of substance abuse
*Smoker
*Food allergies
*Potassium reduced diet
*Score <24 on the Mini-Mental State Exam
*Currently participating or having participated in another clinical trial during the last 2 months prior to the beginning of this 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)
Participants will respond to advertisements and pass a phone screen before coming in for their screening and enrolment. Participants will be allocated a participant number that will be assigned to a treatment code sequence. The products used in this study will be coded (A, B and C). A randomization schedule will be generated using Williams Design in R 2.6.1 using these codes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated a participant number that will be assigned to a treatment code sequence. The products used in this study will be coded (A, B and C). A randomization schedule will be generated using Williams Design in R 2.6.1 using these codes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
This is an acute cross-over, placebo-controlled, double blind, randomized, single centre, clinical trial with three treatment conditions: coffee extract, coffee and placebo.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258205 0
Commercial sector/Industry
Name [1] 258205 0
Nestec
Country [1] 258205 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
Nestec
Address
Vers-Chez-Les-Blanc
Lausanne 26
CH 1000
Country
Switzerland
Secondary sponsor category [1] 257377 0
None
Name [1] 257377 0
Address [1] 257377 0
Country [1] 257377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260188 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 260188 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 260188 0
Australia
Date submitted for ethics approval [1] 260188 0
Approval date [1] 260188 0
24/06/2010
Ethics approval number [1] 260188 0
SUHREC 2010/054

Summary
Brief summary
Participants come for one practice visit where they go through the screening questions and provide informed consent. They also practice on all cognitive and mood tasks they will be doing on their subsequent testing sessions. Participants come for 3 testing sessions at least 1 week apart. At each testing session, they first complete baseline 'mood, cognitive, mood' assessments and doppler ultrasound followed by treatment administration. They complete 'mood, cognitive mood' assessment at 40mins and 120mins post dose and doppler at 90mins post dose
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32011 0
Address 32011 0
Country 32011 0
Phone 32011 0
Fax 32011 0
Email 32011 0
Contact person for public queries
Name 15258 0
Con Stough
Address 15258 0
400 Burwood Rd
Hawthorn VIC 3122
Country 15258 0
Australia
Phone 15258 0
613 9214 8167
Fax 15258 0
Email 15258 0
[email protected]
Contact person for scientific queries
Name 6186 0
Con Stough
Address 6186 0
400 Burwood Rd
Hawthorn VIC 3122
Country 6186 0
Australia
Phone 6186 0
613 9214 8167
Fax 6186 0
Email 6186 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
Dimensions AIA Randomised Placebo-Controlled Trial to Differentiate the Acute Cognitive and Mood Effects of Chlorogenic Acid from Decaffeinated Coffee2013https://doi.org/10.1371/journal.pone.0082897
N.B. These documents automatically identified may not have been verified by the study sponsor.