Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000229976
Ethics application status
Approved
Date submitted
3/02/2020
Date registered
25/02/2020
Date last updated
2/11/2021
Date data sharing statement initially provided
25/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an anti-­inflammatory diet on clinical and biochemical features of knee osteoarthritis: a pilot RCT
Scientific title
The effect of an anti-­inflammatory diet on clinical and biochemical features of knee osteoarthritis: a pilot RCT
Secondary ID [1] 300376 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 315996 0
Condition category
Condition code
Musculoskeletal 314268 314268 0 0
Osteoarthritis
Diet and Nutrition 314269 314269 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The anti-inflammatory diet intervention group will recieve specific anti-inflammatory dietary education and advice through teleconference (Zoom or Phone) and via written material delivered by an Accredited Practising Dietician. These material have been specifically designed by dieticians for this study. Participants will be encouraged to avoid refined carbohydrates, sugar, ultra­processed foods, processed meats and junk foods. The diet will focus on consumption of lean meats, fish, eggs, dairy, fruit, vegetables, nuts, seeds and olive oil. This advice will be supplemented by written material.

There will be a total of 4 points of contact with participants occurring at baseline, 3-weeks, 6-weeks and 9-weeks. During the consultations, participant diet will be assessed, further education provided and troubleshooting of any barriers to adherence. Participants will be asked to record their food intake via a three-day food diary at 3-weeks, 6-weeks and 9-weeks. Dietary information will be collected via hard-copy or phone based app and assessed by an Accredited Practising Dietitian.
Intervention code [1] 316656 0
Lifestyle
Comparator / control treatment
There will no longer be a control intervention for this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322658 0
UpdateFeasibility of conducting a full scale randomised controlled trial. Feasibility assessed by integrity of protocol, recruitment rate and retention/drop-out rate and dietary adherence. Dietary feasibility/adherence will be measured by (3-day food diaries via hard copy or a phone app after baseline, 3-, 6-, 9-weeks, core food analysis, participant-reported adherence and PREDIMED checklist). Feasibility will be further assessed by treatment satisfaction and occurrence of participant-reported adverse events. Post-study interviews will be used to determine potential improvements for future studies. Suitability of chosen primary endpoint will also be assessed. With additional patient reported outcomes measured to determine if other measures are more sensitive to change than the KOOS4.
Timepoint [1] 322658 0
Timepoint: Participant measures will be taken at 0, 3, 6 and 9 weeks with the primary timepoint comparing results between baseline data (0 week) and 9 week time point.
Secondary outcome [1] 379217 0
Knee Osteoarthritis Outcome Score (KOOS4): The average of 4 of the 5 Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales covering pain, symptoms, difficulty in activities of daily living and quality of life.
Timepoint [1] 379217 0
Measured at baseline, 3-weeks, 6 weeks and 9-weeks as per other outcomes.
Secondary outcome [2] 379458 0
Knee pain on a 100mm visual analogue scale (average and worse knee pain during previous 7 days)
Timepoint [2] 379458 0
Measured at baseline, 3-weeks, 6-weeks and 9 weeks as per other outcomes.
Secondary outcome [3] 379459 0
Global rating of symptoms change (7-point likert scale from much worse to much better)
Timepoint [3] 379459 0
Measured at baseline, 3-weeks, 6-weeks and 9 weeks as per other outcomes.
Secondary outcome [4] 379914 0
Health-related quality of life assed with EQ5D-5L
Timepoint [4] 379914 0
Measured at Baseline, 3-weeks, 6-weeks and 9-weeks
Secondary outcome [5] 379915 0
Self-reported physical activity assessed with the International Physical Activity Questionnaire (IPAQ)
Timepoint [5] 379915 0
Measured at Baseline, 3-weeks, 6-weeks and 9-weeks
Secondary outcome [6] 379927 0
Hip to Waist Circumference - measured via tape measure
Timepoint [6] 379927 0
Measured at Baseline, 3-weeks, 6-weeks and 9-weeks
Secondary outcome [7] 380013 0
Analgesic pain medication use. Participants will self-report on their use of analgesic medication at baseline and end of intervention.
Timepoint [7] 380013 0
Measured at Baseline, 3-weeks, 6-weeks and 9-weeks

Eligibility
Key inclusion criteria
-At least moderate knee symptoms (equal to or greater than 4/10 average pain and/or equal to or greater than 5/10 worse pain) during the previous week. Which reflects the international guideline-based clinical diagnosis of osteoarthritis
- Between 40 and 85 years of age at baseline assessment
- Willing to complete a 12-week anti-inflammatory diet intervention and available to attend all assessments
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Another reason than OA for knee symptoms (e.g. tumour, fibromyalgia, referred pain).
- Already participating in a specific anti-inflammatory diet (e.g. low carbohydrate, high-fat, paleo, Mediterranean).
- >5kg weight loss in the past three months (i.e. not weight stable)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No longer necessary
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No longer necessary
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome of feasibility will be assessed using recruitment rate, compliance with the intervention, drop out rate and adverse events.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/03/2020
Actual
3/04/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
30/04/2020
Date of last data collection
Anticipated
31/03/2021
Actual
29/06/2020
Sample size
Target
60
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304800 0
University
Name [1] 304800 0
La Trobe University Bundoora
Country [1] 304800 0
Australia
Primary sponsor type
University
Name
La Trobe University: Research Focus Area: Sport, Exercise and Rehabilitation
Address
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 305145 0
None
Name [1] 305145 0
Address [1] 305145 0
Country [1] 305145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305215 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 305215 0
Ethics committee country [1] 305215 0
Australia
Date submitted for ethics approval [1] 305215 0
16/11/2019
Approval date [1] 305215 0
20/01/2020
Ethics approval number [1] 305215 0
HEC19525

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

Contacts
Principal investigator
Name 99638 0
Prof Peter Brukner
Address 99638 0
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health, Human Services and Sport | College of Science, Health and Engineering | La Trobe University | Victoria 3086 Australia | Health Sciences Building 3 |
Country 99638 0
Australia
Phone 99638 0
+61 418 351 009
Fax 99638 0
Email 99638 0
[email protected]
Contact person for public queries
Name 99639 0
Indiana Cooper
Address 99639 0
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health, Human Services and Sport | College of Science, Health and Engineering | La Trobe University | Victoria 3086 Australia | Health Sciences Building 3 | Room 510
Country 99639 0
Australia
Phone 99639 0
+61 456074048
Fax 99639 0
Email 99639 0
[email protected]
Contact person for scientific queries
Name 99640 0
Adam Geoffrey Culvenor
Address 99640 0
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health, Human Services and Sport | College of Science, Health and Engineering | La Trobe University | Victoria 3086 Australia | Health Sciences Building 3 | Room 510
Country 99640 0
Australia
Phone 99640 0
+61 03 9479 5116
Fax 99640 0
Email 99640 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
EmbaseAn anti-inflammatory diet intervention for knee osteoarthritis: a feasibility study.2022https://dx.doi.org/10.1186/s12891-022-05003-7
N.B. These documents automatically identified may not have been verified by the study sponsor.