Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001288910
Ethics application status
Approved
Date submitted
15/12/2011
Date registered
16/12/2011
Date last updated
9/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of resveratrol in red wine on cognitive function in older adults: Preliminary study
Scientific title
The effect of resveratrol in red wine on cognitive function in older adults: Preliminary study
Secondary ID [1] 273357 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function in older adults 285408 0
Absorption rates of resveratrol 285409 0
Condition category
Condition code
Alternative and Complementary Medicine 285588 285588 0 0
Herbal remedies
Mental Health 285589 285589 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resveratrol belongs to a class of polyphenolic compounds called stillbenes, found largely in the skins of red grapes and root of Japanese knotweed. It is a fat-soluble compound typically used in oriental medicine to treat diseases of the blood vessels, heart and liver. An increasing body of evidence from in vitro, animal model and ex vivo studies suggest that resveratrol has the potential to prevent or reduce the risk of certain diseases such as cardiovascular disease, certain cancers (DNA-protective effects) and cognitive dysfunction or dementias.

This study is a placebo-controlled, double-blind, randomised, repeated groups study, with a 7-day washout period between treatments.

Participants will be required to attend 2 study visits. Visits will be scheduled to begin in the mornings as participants will be required to fast prior to testing. Each visit will progress in the same fashion and last for approximately 2.5 hours.

Participants will complete a baseline 20-minute cognitive battery comprised of 2 repetitions of the Cognitive Demand Battery which consists of the serial three subtraction task, serial seven subtraction task and the Rapid Visual Information Processing Task. Following this a fasting blood sample will be taken as a baseline measure. Participants will then be given their treatment for the day.

Participants will be randomised to receive either:
1) 100mg of grape derived resveratrol in 100ml red wine
2) 100ml red wine,

such that at the conclusion of the study all participants will have received both treatments.

A 45 minute absorption period is required prior to a second blood sample being taken. Following this, participants will complete a 60 minute cognitive battery comprised of 6 repetitions of the CDB. Following this, participants will be required to give a third blood sample. Finally, following a further 30 minutes, a fourth blood sample will be taken.
Intervention code [1] 283896 0
Prevention
Intervention code [2] 283897 0
Behaviour
Comparator / control treatment
2) 100ml red wine (the same red wine not enhanced with resveratrol)
Control group
Placebo

Outcomes
Primary outcome [1] 286155 0
To assess the effects of a daily moderate amount of resveratrol-enhanced red wine on cognitive performance in older adults using the Cognitive Demand Battery (CDB) which consists of the serial three subtraction task, serial seven subtraction task and the Rapid Visual Information Processing Task
Timepoint [1] 286155 0
- At Baseline participants will complete 2 repetitions of the CDB
- 45 minutes post dose participants will complete 6 repetitions of the CDB
Secondary outcome [1] 295254 0
To determine whether the dose of resveratrol (100 mg) is significant enough to reach detectable concentrations in the body.
Timepoint [1] 295254 0
10mL of blood will be taken a total at baseline, 45 minutes post dose, 105 minutes post dose and 135 minutes post dose.

Eligibility
Key inclusion criteria
Participants who meet the following eligibility criteria will be recruited in the trial:

1. Healthy non-smoking males and females aged 65 or older.

2. No history of anxiety, depression or epilepsy.

3. Not taking any form of medication within 5 days of participation in the study (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study.

4. Are willing and able to participate in all scheduled visits, treatment plan, dietary restrictions, tests and other trial procedures according to the protocol. Also comfortable with computers.

5. Understand the rating scales and computer tests (as judged by the study coordinator)

6. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants presenting with any of the following will not be included in the trial:

1. Cigarette smoker

2. Heavy drinker of alcohol (averages more than 2 standard drinks per day).

3. History of anxiety, depression, psychiatric disorders or epilepsy

4. Currently taking (or have taken in the last 4 weeks) any anticoagulant or anti-platelet medications (such as warfarin, aspirin and others)

5. Currently taking any illicit drugs and/or a history of substance abuse.

6. Allergies to any treatment products

7. Current participation in any other trials involving investigational or marketed products within 30 days prior to the practice day.

8. Any clinically relevant abnormalities in a volunteer’s medical history, physical examination, or results of laboratory tests.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through advertising and word of mouth.

To minimize bias this study will employ both randomization and blinding.

Randomization of participants to treatment groups will be determined by random allocation. Eligible, recruited participants will be assigned a participant number. The randomisation order that has been placed next to the participant’s number will be the allocated treatment order for that individual.

Blinding will be achieved by enlisting a person outside of the project to code the treatments, and maintain the key to this code until data collection is completed. The codes will only be broken in an emergency, such as an SAE that requires knowledge of the treatment being taken in order to manage a participant’s condition. The principle investigator and ethics committee will be informed within 24 hours of the code-break envelope being opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party will generate the randomisation sequence using a computerised sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2012
Actual
4/01/2012
Date of last participant enrolment
Anticipated
Actual
1/02/2012
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284388 0
Other Collaborative groups
Name [1] 284388 0
Australian Wine Research Institute
Country [1] 284388 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
PO Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 283317 0
None
Name [1] 283317 0
Nil
Address [1] 283317 0
Nil
Country [1] 283317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286347 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 286347 0
Ethics committee country [1] 286347 0
Australia
Date submitted for ethics approval [1] 286347 0
Approval date [1] 286347 0
07/12/2011
Ethics approval number [1] 286347 0
SUHREC Project 2011/030

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

Contacts
Principal investigator
Name 33372 0
Prof Prof Andrew Scholey
Address 33372 0
H24, Po Box 218 Hawthorn, Vic, 3122
Country 33372 0
Australia
Phone 33372 0
613 92148932
Fax 33372 0
Email 33372 0
[email protected]
Contact person for public queries
Name 16619 0
Rebecca King
Address 16619 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 16619 0
Australia
Phone 16619 0
613 92145087
Fax 16619 0
Email 16619 0
[email protected]
Contact person for scientific queries
Name 7547 0
Professor Andrew Scholey
Address 7547 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 7547 0
Australia
Phone 7547 0
613 9214 8932
Fax 7547 0
Email 7547 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.