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Trial registered on ANZCTR


Registration number
ACTRN12618001184268
Ethics application status
Approved
Date submitted
6/07/2018
Date registered
17/07/2018
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of fruit anthocyanins in participants attending a cognitive rehabilitation group for mild cognitive impairment: A randomised controlled trial.
Scientific title
The effect of a dietary intervention with fruit-derived anthocyanins in participants attending a cognitive rehabilitation group for mild cognitive impairment: A randomised controlled trial.
Secondary ID [1] 295536 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 308489 0
Endothelial dysfunction 308490 0
Condition category
Condition code
Mental Health 307467 307467 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 307468 307468 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to evaluate the combined effect of a cognitive rehabilitation group (CRG) with intake of Queen Garnet plum (QGP) juice, to optimise cognition in adults with mild cognitive impairment (MCI). Biomedical measures would contribute to an understanding of the mechanisms of action associated with cognitive improvements. The study would include an 8week, doubleblind randomised controlled trial with two arms, CRG plus control intervention, and CRG plus 250mL QGP juice daily for 8 weeks (consumed in one sitting or in smaller doses throughout the day), using MCI patients referred to the ISLHD Geriatric Outpatient Services or Rehabilitation and Medical Psychology Department. Recruitment and research consent of participants will occur
within ISLHD clinics, with an aim of 72 subjects. Participants will return the empty bottles in order to assess intervention compliance. Participants will attend a data collection session at baseline, conducted by Clinical Neuropsychologist and a Research Assistant, where participants will undergo the neuropsychological test battery, collection of demographic data, a food frequency questionnaire and instructions for a 4day
food record, and blood collection. Across the six weeks of the CRG participants will learn about the functional memory processes of attention/encoding, storage and retrieval in collective educational sessions. The program will present how to apply internal and external techniques and provide strategies to enhance these processes. The groups will be comprised of 4 to 12 subjects, one sessions of 2 hours per week and adherence will be monitored by an attendance log. Subjects will be provided a 24hour Blood Pressure monitoring device, a urine and faecal sample collection kit, and their supplement/placebo to commence. These assessment procedures will be repeated at 8 weeks.
Intervention code [1] 301629 0
Treatment: Other
Intervention code [2] 301630 0
Rehabilitation
Intervention code [3] 301631 0
Behaviour
Comparator / control treatment
The study would include an 8week, doubleblind randomised controlled trial with two arms, The intervention consist of a daily dose of 250mL of QGP juice and the control treatment consist of a daily dose of 250mL of coloured apricot juice to resemble QGP juice as a strategy to maintain the double-blind aspect of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 306504 0
The Comprehensive Assessment of Prospective Memory (both self-report and other-report)
Timepoint [1] 306504 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [1] 348705 0
Microvascular reactivity: Cutaneous vascular reactivity will be measured by using the Laser Speckle Contrast Imaging (LSCI) technology (Pericam PSI System, Perimed AB, Järfälla, Sweden), using a vascular reactivity test, the post-occlusive reactive hypermia (PORH) in a temperature controlled room (22.5°C ±1). The baseline skin perfusion measurement in volar side of the left forearm will take 2 minutes. Then, arterial occlusion will be induced and maintained during 3 minutes using a blood pressure cuff around the upper arm inflated to a pressure of 50-60 mmHg above systolic pressure reading. After the blood pressure cuff is released, the PORH response will be recorded for more 3 minutes, totalizing 8 minutes of reading. Parameters of microvascular blood flow will be presented in perfusion units and as cutaneous vascular conductance (CVC) by dividing by the mean arterial pressure to give the CVC in APU/mmHg.
Timepoint [1] 348705 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [2] 349354 0
Blood pressure. Blood pressure will be measured using a 24h ambulatory blood pressure monitor (Welch Allyn ABPM 7100) collecting readings each 30 minutes during daytime and each 1 hour during night time.
Timepoint [2] 349354 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [3] 349356 0
Gut microbiota. Faecal samples will be collected at using a microbiome collection kit (SmartGuttm, Ubiome – USA) and stored at -80 °C until be analysed by Illumina® Next-Generation sequencing by a microbial genomics company (Ubiome – USA).
Timepoint [3] 349356 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [4] 349469 0
Strategies Used Questionnaire (examining number of internal and external strategies used)
*Primary outcome
Timepoint [4] 349469 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [5] 349470 0
Mood Measure: Depression Anxiety Stress Scale-21 item
*Primary outcome
Timepoint [5] 349470 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [6] 349471 0
Rey Auditory Verbal Learning Test (auditory anterograde memory functioning)
*Primary outcome
Timepoint [6] 349471 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [7] 349472 0
Complex Figure Tests (anterograde visual memory)
*Primary outcome
Timepoint [7] 349472 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [8] 349473 0
The Royal Prince Alfred Prospective Memory Test (prospective memory)
*Primary outcome
Timepoint [8] 349473 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [9] 349474 0
Test of Premorbid Functioning (premorbid IQ estimate)
*Primary outcome
Timepoint [9] 349474 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [10] 349475 0
WAIS-IV Digit Span Subtest (attention and working memory)
*Primary outcome
Timepoint [10] 349475 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [11] 349476 0
Trail Making Test A and B (speed of information processing and executive functioning)
*Primary outcome
Timepoint [11] 349476 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [12] 349477 0
Test of Everyday Attention Telephone Search (visual attention)
*Primary outcome
Timepoint [12] 349477 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [13] 349478 0
Oxidized-LDL (blood)
Timepoint [13] 349478 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [14] 349479 0
Intercellular Adhesion Molecule 1 (ICAM-1) (blood)
Timepoint [14] 349479 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [15] 349480 0
Vascular cell adhesion molecule 1 (VCAM-1) (blood)
Timepoint [15] 349480 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [16] 349481 0
e-selectin (blood)
Timepoint [16] 349481 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [17] 349482 0
Monocyte chemoattractant protein 1 (MCP1) (blood)
Timepoint [17] 349482 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [18] 349483 0
Endothelin-1 (blood)
Timepoint [18] 349483 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)
Secondary outcome [19] 349484 0
Serum angiotensin-II (ELISA)
Timepoint [19] 349484 0
Baseline: one day before starting juice interventions (15 days before start of CRG).
End of study: one week after the last CRG section (participants still drinking the juice intervention)

Eligibility
Key inclusion criteria
Mild cognitive impairment; (Mini Mental State Examination (MMSE) score of 24-30; memory complaints
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any form of dementia/neurodegenerative condition, are not able to meet the above criteria, their tested IQ is less than 80, they are unable to speak English, have a history of psychiatric (other than mood) disorder, or any other significant neurological history including head injury, epilepsy, or tumour; intake of anti-inflammatory and antibiotics.

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)
Allocation was concealed as the person in charge to allocate subjects in groups was not involved in recruitment and assessment for eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization by block created by a software computer conducted by a person not involved in analysis/data collection.
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
G-Power was used to calculate power for the critical interaction between group and time on the primary outcome measure, the Rey Auditory Verbal Learning Test (RAVLT), as our previous studies have demonstrated a strong effect on this measure of anthocyanin supplementation in groups with memory impairment (Kent et al., 2015). As this group may not be as impaired as those in our previous study of dementia patients, power is set conservatively to detect a small to medium effect (f =.15) on this measure, therefore 72 participants are required to achieve a power of 0.8 (36 participants per experimental condition; i.e., 6 patients per CRG x 12 groups). Cognitive outcomes and data from the biomarkers will be evaluated using repeated measures
ANOVA and/or mixed linear modelling to evaluate changes due to the interventions. Covariates may be included in these analyses if necessary. In addition, correlation and regression methods will be used to examine the relationships between measures, particularly between changes in biomarkers and any significant changes on the cognitive measures. Results of the 4day food records and the FFQ will be assessed using FoodWorks 8 Professional (Copyright 2012 2017 Xyris Software (Australia) Pty Ltd). An Australian flavonoid food composition database, recently developed by our group, and based on the US Department of Agriculture (USDA) database, will be used to analyse background dietary flavonoid intake.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/03/2018
Date of last participant enrolment
Anticipated
25/10/2018
Actual
Date of last data collection
Anticipated
29/11/2018
Actual
Sample size
Target
72
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11260 0
Port Kembla Hospital - Warrawong
Recruitment postcode(s) [1] 23138 0
2502 - Warrawong

Funding & Sponsors
Funding source category [1] 299891 0
Charities/Societies/Foundations
Name [1] 299891 0
Illawarra Health and Medical Research Institute (IHMRI)
Country [1] 299891 0
Australia
Funding source category [2] 299945 0
University
Name [2] 299945 0
SMAH - Health Impacts Research Cluster Small Research Grants Scheme
Country [2] 299945 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave Wollongong NSW 2522 Australia
Country
Australia
Secondary sponsor category [1] 299251 0
Charities/Societies/Foundations
Name [1] 299251 0
Illawarra Health and Medical Research Institute (IHMRI)
Address [1] 299251 0
Building 32 University of Wollongong, Northfields Avenue, Wollongong NSW 2522
Country [1] 299251 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300760 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 300760 0
Research Services Office
Building 20, Level 1
University of Wollongong,
Northfields Ave
Wollongong NSW 2522
Ethics committee country [1] 300760 0
Australia
Date submitted for ethics approval [1] 300760 0
15/11/2017
Approval date [1] 300760 0
30/01/2018
Ethics approval number [1] 300760 0
2017/581

Summary
Brief summary
The study aims to evaluate the combined effect of a cognitive rehabilitation group (CRG) with intake of Queen Garnet plum (QGP) juice, to optimise cognition in adults with mild cognitive impairment (MCI). Biomedical measures would contribute to an understanding of the mechanisms of action associated with cognitive improvements. The study would include an 8week, doubleblind randomised controlled trial with two arms, CRG plus placebo, and CRG plus 250mL QGP juice, using MCI patients referred to the ISLHD Geriatric Outpatient Services or Rehabilitation and Medical Psychology Department. Recruitment and research consent of participants will occur within ISLHD clinics, with an aim of 72 subjects. Participants will attend a data collection session at baseline, conducted by Clinical Neuropsychologist and a Research Assistant, where participants will undergo the neuropsychological test battery, collection of demographic data, a food frequency questionnaire and instructions for a 4day food record, and blood collection. Subjects will be provided a 24hour Blood Pressure monitoring device, a urine and faecal sample collection kit, and their supplement/placebo to commence. These assessment procedures will be repeated at 8 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84722 0
A/Prof Karen Chartlon
Address 84722 0
University of Wollongong
Office B41.315
Northfields Ave
Wollongong NSW 2522
Country 84722 0
Australia
Phone 84722 0
+61 2 4221 4754
Fax 84722 0
Email 84722 0
karenc@uow.edu.au
Contact person for public queries
Name 84723 0
A/Prof Karen Chartlon
Address 84723 0
University of Wollongong
Office B41.315
Northfields Ave
Wollongong NSW 2522
Country 84723 0
Australia
Phone 84723 0
+61 2 4221 4754
Fax 84723 0
Email 84723 0
karenc@uow.edu.au
Contact person for scientific queries
Name 84724 0
A/Prof Karen Chartlon
Address 84724 0
University of Wollongong
Office B41.315
Northfields Ave
Wollongong NSW 2522
Country 84724 0
Australia
Phone 84724 0
+61 2 4221 4754
Fax 84724 0
Email 84724 0
karenc@uow.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23651Informed consent form  karenc@uow.edu.au
23652Ethical approval https://www.uow.edu.au/research-and-innovation/researcher-support/ethics/human-ethics/ 

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFood anthocyanins decrease concentrations of TNF-alpha in older adults with mild cognitive impairment: A randomized, controlled, double blind clinical trial.2021https://dx.doi.org/10.1016/j.numecd.2020.11.024
EmbaseAnthocyanin intake is associated with improved memory in older adults with mild cognitive impairment.2022https://dx.doi.org/10.1016/j.nutres.2022.04.003
N.B. These documents automatically identified may not have been verified by the study sponsor.