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Trial registered on ANZCTR


Registration number
ACTRN12614001298606
Ethics application status
Approved
Date submitted
21/11/2014
Date registered
11/12/2014
Date last updated
11/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of flavonoids from cherries on memory and cognition in older adults with mild to moderate dementia
Scientific title
Assessment of change in cognitive function in people with mild to moderate dementia after daily consumption of flavonoid-rich cherry juice or low-flavonoid apple juice over 12 weeks.
Secondary ID [1] 285716 0
Nil
Universal Trial Number (UTN)
U1111-1164-4240
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 293590 0
Condition category
Condition code
Diet and Nutrition 293880 293880 0 0
Other diet and nutrition disorders
Neurological 293956 293956 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over 12 weeks participants receive 200ml/day of orally administered cherry juice containing 186mg/L anthocyanins (ORAC 59 TE/g). The sweet, 100% Bing cherry juice is produced using a novel method that aims to retain the phenolic bioactives, developed by a research company (Agritechnology) based in Orange, NSW, Australia. Adherence to the intervention was assessed using a self reported diary check box and monitoring of returned juice bottles.
Intervention code [1] 290672 0
Lifestyle
Comparator / control treatment
Over 12 weeks participants receive 200ml/day of commercially produced apple juice containing 0.02mg/L Anthocyanins (ORAC 15.5 TE/g). The apple juice is produced by Appledale, Orange, NSW, Australia.
Control group
Active

Outcomes
Primary outcome [1] 293662 0
Cognitive function was assessed using a battery of seven cognitive tests, including the Rey Auditory Verbal Learning Test (RAVLT), the self-ordered pointing task (SOPT), the Boston naming test, the trail making test (TMT), digit span backwards task and category and letter verbal fluency.
Timepoint [1] 293662 0
6 weeks and 12 weeks after baseline
Secondary outcome [1] 311531 0
Anthropometrics including height, weight and muscle mass measured using bioelectric impedence scales.
Timepoint [1] 311531 0
6 and 12 weeks post baseline.
Secondary outcome [2] 311686 0
Biomarkers of inflammation - IL-6 and CRP measured using a serum assay.
Timepoint [2] 311686 0
6 and 12 weeks after baseline
Secondary outcome [3] 311687 0
Depression measured using Geriatric Depression Scale
Timepoint [3] 311687 0
6 and 12 weeks after baseline
Secondary outcome [4] 311801 0
Blood pressure measured using an OMRON blood pressure monitor, at rest and in triplicate.
Timepoint [4] 311801 0
6 and 12 weeks after baseline.
Secondary outcome [5] 311802 0
Hand-grip strength measured using a JAMAR hand grip dynomometer.
Timepoint [5] 311802 0
6 and 12 weeks after baseline.
Secondary outcome [6] 311803 0
Mid-arm and mid-calf measurements were recorded using a standard measuring tape.
Timepoint [6] 311803 0
6 and 12 weeks post baseline.

Eligibility
Key inclusion criteria
>70years
MMSE score 10 - 24
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
MMSE > 24
Confounding health conditions such as dysphasia.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290291 0
University
Name [1] 290291 0
Illawarra Health and Medical research Institute, University of Wollongong.
Address [1] 290291 0
Building 32,
University of Wollongong
Wollongong, NSW
Australia 2522
Country [1] 290291 0
Australia
Primary sponsor type
University
Name
Illawarra Health and Medical Research Institute, University of Wollgongong
Address
Building 32,
University of Wollongong
Wollongong, NSW
Australia 2522
Country
Australia
Secondary sponsor category [1] 289002 0
University
Name [1] 289002 0
University of Wollongong
Address [1] 289002 0
University of Wollongong
Wollongong, NSW
Australia 2522
Country [1] 289002 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291999 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 291999 0
University of Wollongong
Wollongong, NSW
Australia, 2522
Ethics committee country [1] 291999 0
Australia
Date submitted for ethics approval [1] 291999 0
20/04/2011
Approval date [1] 291999 0
07/07/2011
Ethics approval number [1] 291999 0
HE11/175

Summary
Brief summary
This study aims to assess whether further cognitive decline can be delayed or prevented in people with mild to moderate dementia through the consumption of flavonoids in cherry juice over 12 weeks. Secondary outcomes included anti-inflammatory effects, changes in functional and physical ability and depressive symptomatology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52990 0
A/Prof Karen Charlton
Address 52990 0
School of Medicine
Faculty of Science, Medicine and Health University of Wollongong NSW 2522
Country 52990 0
Australia
Phone 52990 0
+61 2 4221 4754
Fax 52990 0
+61 2 4221 3486
Email 52990 0
karen_charlton@uow.edu.au
Contact person for public queries
Name 52991 0
Ms Katherine Caldwell
Address 52991 0
School of Medicine
Faculty of Science, Medicine and Health University of Wollongong NSW 2522
Country 52991 0
Australia
Phone 52991 0
+61 2 4221 4274
Fax 52991 0
Email 52991 0
katherine_caldwell@uow.edu.au
Contact person for scientific queries
Name 52992 0
Ms Katherine Caldwell
Address 52992 0
School of Medicine
Faculty of Science, Medicine and Health University of Wollongong NSW 2522
Country 52992 0
Australia
Phone 52992 0
+61 2 4221 4274
Fax 52992 0
Email 52992 0
katherine_caldwell@uow.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary