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Trial registered on ANZCTR


Registration number
ACTRN12618001941257
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
29/11/2018
Date last updated
29/11/2018
Date data sharing statement initially provided
29/11/2018
Date results information initially provided
29/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
ReJUICE your pain: The effect of dietary advice and a dietary supplement on pain outcomes in people experiencing chronic pain
Scientific title
ReJUICE your pain: The effect of dietary advice and a dietary supplement on pain outcomes in patients attending a tertiary pain service
Secondary ID [1] 296669 0
Rainbow Foundation grant Hunter Medical Research Institute 15-66 "Nutrition’s role in chronic pain management" on 30/06/2018
Universal Trial Number (UTN)
U1111-1224-3484
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 310511 0
Condition category
Condition code
Anaesthesiology 309225 309225 0 0
Pain management
Neurological 309273 309273 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intervention components will be tested: 1) Personalized dietary advice provided via telehealth and 2) Dietary supplement.

The dietary supplement is a fruit juice. Two fruit juices will be used 1) Active fruit juice (high in anthocyanins) and 2) Placebo fruit juice (no anthocyanins).

Participants will be randomized into one of four groups
Study arm 1: Personalized dietary advice and active fruit juice
Study arm 2: Personalized dietary advice and placebo fruit juice
Study arm 3: Waitlist control and active fruit juice
Study arm 4: Waitlist control and placebo fruit juice

Personalized dietary advice: Participants will receive up to three 30-45 minute consultations (2 recommended, 1 optional) with an Accredited Practicing Dietitian (APD). This will be provided via Avaya Scopia (the telehealth software used by Hunter New England health) or via phone calls. Prior to the consult, participants will complete the Australian Eating Survey (AES) Food Frequency Questionnaire which generates a report comparing dietary intake to national guidelines. Participants will be sent their AES report prior to the first consultation. They will also be asked to complete a personalised nutrition questionnaire (PNQ) to identify factors which may affect their eating behaviors which will allow the APD to prioritize barriers that may affect each participant. There is a toolbox associated with the PNQ which lists intervention strategies and resources linked with each factor. The APD used the PNQ and toolbox to discuss strategies and goal setting. A summary of the session and links to relevant resources will be emailed to each participant at the end of the session. The resources include websites and handouts which were sourced from government departments, The Dietitians Association of Australia, Nutrition Education Materials Online, Australian Healthy Food Guide and Practice-based Evidence in Nutrition

Fruit juice: participants will receive 42X 250ml bottles of fruit juice to consume one per day for a 6 week period. The anthocyanin content of this juice ranges from approximately 30mg/100g to >100mg/100g depending on the conditions of the season when the fruit was grown. A tick-box calendar will be provided to monitor compliance.
Intervention code [1] 312980 0
Lifestyle
Intervention code [2] 312981 0
Behaviour
Intervention code [3] 312982 0
Treatment: Other
Comparator / control treatment
The control for the personalized dietary advice is a waitlist control. These participants will be instructed to continue with their usual diet and not make any dietary changes. At the end of the 6 weeks they will be given access to the personalised dietary component.

The placebo fruit juice will be given in the same quantity and same instructions. The placebo juice has no anthocyanins.
Control group
Placebo

Outcomes
Primary outcome [1] 308192 0
Feasibility measured using a questionnaire provided to participants at the final session. The questions included were designed for the study and include a series of likert scale based questions with answers ranging from strongly disagree to strongly agree or very unsatisfied to very satisfied

Timepoint [1] 308192 0
End of the intervention (6 weeks)
Primary outcome [2] 308193 0
Participants pain severity which will be measured using the Brief Pain Inventory
Timepoint [2] 308193 0
End of the intervention (6 weeks)
Primary outcome [3] 308280 0
Participants pain self-efficacy which will be measured using the Pain Self Efficacy Questionnaire
Timepoint [3] 308280 0
End of the intervention (6 weeks)
Secondary outcome [1] 354205 0
Presence of food addiction traits, YALE food addiction scale
Timepoint [1] 354205 0
End of the intervention (6 weeks)
Secondary outcome [2] 354206 0
Serum antioxidant capacity (Oxygen Radical Absorbance Capacity)
Timepoint [2] 354206 0
End of the intervention (6 weeks)
Secondary outcome [3] 354207 0
Height - automatic stadiometer
Timepoint [3] 354207 0
End of the intervention (6 weeks)
Secondary outcome [4] 354208 0
Blood pressure measured using BP+ supra systolic oscillometric central blood pressure monitor
Timepoint [4] 354208 0
End of the intervention (6 weeks)
Secondary outcome [5] 354209 0
Skin colour, presence of caroteniods in the skin - photographs were taken on the palm of the hand, and either side of the elbow using a spectrophotometer.
Timepoint [5] 354209 0
End of the intervention (6 weeks)
Secondary outcome [6] 354367 0
Inflammation biomarkers (CRP, IL-6, TNFa)
Timepoint [6] 354367 0
End of the intervention (6 weeks)
Secondary outcome [7] 354369 0
Weight (InBody 770 Body composition and body water analyser)
Timepoint [7] 354369 0
End of the intervention (6 weeks)
Secondary outcome [8] 354370 0
Body composition (InBody 770 Body composition and body water analyser)
Timepoint [8] 354370 0
End of the intervention (6 weeks)
Secondary outcome [9] 354371 0
Waist circumference (measured by researcher using measuring tape half way between top of hip and bottom rib)
Timepoint [9] 354371 0
End of the intervention (6 weeks)
Secondary outcome [10] 354372 0
Arterial stiffness measured using BP+ supra systolic oscillometric central blood pressure monitor
Timepoint [10] 354372 0
End of the intervention (6 weeks)
Secondary outcome [11] 354489 0
Serum antioxidant capacity ( Ferric Reducing Ability of Plasma)
Timepoint [11] 354489 0
End of the 6 week intervention
Secondary outcome [12] 354504 0
Participants pain catastrophising which will be measured using the Pain Catastrophising Scale
Timepoint [12] 354504 0
End of the intervention (6 weeks)

Eligibility
Key inclusion criteria
Referred to Hunter Integrated Pain Service for the treatment of chronic pain
Access to reliable broadband internet
Able to attend two in person measurement sessions at the University of Newcastle
Willing to provide fasting blood sample
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intolerance to fruit
Pregnant
Have a pacemaker or cochlear implant
Have a serious medical condition (e.g. insulin controlled diabetes)

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)
Randomisation was determined using a computer generated randomisation which was conducted by one of the researchers who was not involved in data collection. This was then placed in envelops which were opened by the researcher collecting the data at the end of the baseline session
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Descriptive statistics and linear mixed models

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
Recruitment postcode(s) [1] 24804 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 301249 0
Charities/Societies/Foundations
Name [1] 301249 0
Hunter Medical Research Institute, Rainbow Foundation
Address [1] 301249 0
Lot 1 Kookaburra Cct, New Lambton Heights, NSW, 2305
Country [1] 301249 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive,
University of Newcastle
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 300883 0
University
Name [1] 300883 0
The University of Newcastle
Address [1] 300883 0
University Drive,
University of Newcastle
Callaghan
NSW 2308
Country [1] 300883 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301987 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301987 0
Locked Bag No 1, New Lambton, NSW, 2305
Ethics committee country [1] 301987 0
Australia
Date submitted for ethics approval [1] 301987 0
Approval date [1] 301987 0
29/08/2017
Ethics approval number [1] 301987 0
17/07/19/4.04
Ethics committee name [2] 301992 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 301992 0
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [2] 301992 0
Australia
Date submitted for ethics approval [2] 301992 0
Approval date [2] 301992 0
04/09/2017
Ethics approval number [2] 301992 0
H-2017-0295

Summary
Brief summary
The purpose of this study is to test the feasibility and effectiveness of conducting a nutrition intervention with patients experiencing chronic pain who attend Hunter Integrated Pain Service. Hypothesis: Participants who receive the personalized dietary advice and high anthocyanin concentration fruit juice will have a greater reduction in pain scores compared to those randomized to the waitlist control plus placebo fruit juice group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88774 0
Prof Clare Collins
Address 88774 0
School Health Sciences,
HA12, Hunter Building
The University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 88774 0
Australia
Phone 88774 0
+61 249215646
Fax 88774 0
Email 88774 0
clare.collins@newcastle.edu.au
Contact person for public queries
Name 88775 0
Prof Clare Collins
Address 88775 0
School Health Sciences,
HA12, Hunter Building
The University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 88775 0
Australia
Phone 88775 0
+61 249215646
Fax 88775 0
Email 88775 0
clare.collins@newcastle.edu.au
Contact person for scientific queries
Name 88776 0
Prof Clare Collins
Address 88776 0
School Health Sciences,
HA12, Hunter Building
The University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 88776 0
Australia
Phone 88776 0
+61 249215646
Fax 88776 0
Email 88776 0
clare.collins@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary