Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000220369
Ethics application status
Approved
Date submitted
6/02/2017
Date registered
9/02/2017
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of consumption of fruit juice on blood pressure and cognition in older adults over 8 weeks
Scientific title
Effect of consumption of fruit anthocyanin on blood pressure and cognition in older adults over 8 weeks
Secondary ID [1] 291085 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Pressure 301886 0
Memory and Cognition 301887 0
Inflammation markers 301889 0
Nutritional status 301890 0
Change in gut microbiota population 308415 0
Condition category
Condition code
Cardiovascular 301557 301557 0 0
Hypertension
Neurological 301558 301558 0 0
Neurodegenerative diseases
Metabolic and Endocrine 301559 301559 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, double-blind, controlled, crossover trial will be conducted. Consenting participants will be randomly allocated to either an intervention (Queen Garnet Plum juice) or a control arm (blackcurrant flavoured cordial) by independently computer-generated block randomisation. All researchers will be blinded to the allocation order and encoding broken after data analysis.
Intervention: Each arm will last for eight weeks with a 4-week washout period in between, and thereafter allocation. Participants will receive 200mL/day of QGP juice (intervention arm) or commercially available blackcurrant cordial (control arm). Beverages will be delivered to participants homes weekly, in opaque plastic bottles. The QGP fresh fruit will be provided in-kind by Nutrafruit Pty Ltd and the juice produced and bottled by Department of Agriculture Fisheries and Forestry, Queensland, using a novel method to retain the bioactives. Unconsumed juice will be collected for compliance, and urinary biomarker metabolites assessed.
Intervention code [1] 297071 0
Treatment: Other
Comparator / control treatment
The control treatment will be commercially available blackcurrant cordial which has similar amount of vitamin C as the QGPj but negligible amount of anthocyanin
Control group
Placebo

Outcomes
Primary outcome [1] 300968 0
Blood pressure will be measured using Ambulatory Blood Pressure Monitors (ABPM), measuring blood pressure over 24 hours
Timepoint [1] 300968 0
0 week (start of the trial) and 8th week (end of each arm)
Primary outcome [2] 300969 0
Cognitive function and memory (a composite primary outcome) will be assessed using five cognitive tests, including;
1. The Rey auditory verbal learning test (RAVLT): measure of verbal learning and memory
2. The Boston naming test: assesses confrontational naming related to semantic memory
3. the trail making test (TMT): TMT A and B will evaluate executive function, with the relative difference between B and A used as the measure
4. Digit span backwards task: examines short-term memory storage and executive control processes
5. Category and letter verbal fluency: measure of executive function.
Timepoint [2] 300969 0
0 week (start of the trial) and 8th week (end of each arm)
Primary outcome [3] 302795 0
Gut microbiota population: sample will be collected using Ubiome (TM) stool sample swab and assessed using 16S rDNA gene sequencing for bacteria.
Timepoint [3] 302795 0
0 week (baseline measurement), 8th week (and of arm 1) and 8th week (end of arm 2)
Secondary outcome [1] 331295 0
Inflammatory bio-markers (BDNF and CRP) measured from collected blood samples.
Timepoint [1] 331295 0
0 week (start of the trial) and 8th week (end of each arm)

Eligibility
Key inclusion criteria
55+ years
Healthy
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Uncontrolled hypertension (Blood Pressure: >160/95 on day of testing)
2. Dementia (any level)
3. Any fruit allergies
4. Type 1 (Insulin dependent) diabetes
5. Any other unstable physical or mental health condition
6. Have difficulty swallowing.

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)
Simple randomisation using a randomisation table created by computer software.
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
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2017
Actual
7/11/2017
Date of last participant enrolment
Anticipated
30/12/2017
Actual
22/02/2018
Date of last data collection
Anticipated
23/07/2018
Actual
23/05/2018
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15243 0
2500 - Wollongong
Recruitment postcode(s) [2] 15244 0
2517 - Russell Vale
Recruitment postcode(s) [3] 15245 0
2518 - Corrimal
Recruitment postcode(s) [4] 15246 0
2525 - Figtree

Funding & Sponsors
Funding source category [1] 295503 0
Other Collaborative groups
Name [1] 295503 0
2016 University Global Partnership Network (UGPN) Grants
Country [1] 295503 0
Australia
Primary sponsor type
Individual
Name
Karen Charlton
Address
School of Medicine, Faculty of Science, Medicine and Health
University of Wollongong NSW 2522 Australia
Country
Australia
Secondary sponsor category [1] 294324 0
Individual
Name [1] 294324 0
Ezinne Igwe
Address [1] 294324 0
School of Medicine, Faculty of Science, Medicine and Health
University of Wollongong NSW 2522 Australia
Country [1] 294324 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296831 0
UNIVERSITY OF WOLLONGONG/ILLAWARRA SHOALHAVEN LOCAL HEALTH DISTRICT HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 296831 0
Ethics committee country [1] 296831 0
Australia
Date submitted for ethics approval [1] 296831 0
04/07/2016
Approval date [1] 296831 0
16/08/2016
Ethics approval number [1] 296831 0
HE16/278

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1438 1438 0 0
/AnzctrAttachments/372276-16-278 Approval 160816.pdf (Ethics approval)
Attachments [2] 1440 1440 0 0
/AnzctrAttachments/372276-PIS RCT.docx (Participant information/consent)
Attachments [3] 1441 1441 0 0
/AnzctrAttachments/372276-Consent form.docx (Participant information/consent)

Contacts
Principal investigator
Name 72162 0
A/Prof Karen Charlton
Address 72162 0
School of Medicine, Faculty of Science, Medicine and Health
University of Wollongong NSW 2522 Australia
Country 72162 0
Australia
Phone 72162 0
+61 2 4221 4754
Fax 72162 0
Email 72162 0
[email protected]
Contact person for public queries
Name 72163 0
Ezinne Igwe
Address 72163 0
School of Medicine, Faculty of Science, Medicine and Health
University of Wollongong NSW 2522 Australia
Country 72163 0
Australia
Phone 72163 0
+61 24 239 2219
Fax 72163 0
Email 72163 0
[email protected]
Contact person for scientific queries
Name 72164 0
Karen Charlton
Address 72164 0
School of Medicine, Faculty of Science, Medicine and Health
University of Wollongong NSW 2522 Australia
Country 72164 0
Australia
Phone 72164 0
+61 2 4221 4754
Fax 72164 0
Email 72164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseLow anthocyanin plum nectar does not impact cognition, blood pressure and gut microbiota in healthy older adults: A randomized crossover trial.2020https://dx.doi.org/10.1016/j.nutres.2020.08.003
N.B. These documents automatically identified may not have been verified by the study sponsor.