Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000440729
Ethics application status
Approved
Date submitted
11/03/2022
Date registered
18/03/2022
Date last updated
9/05/2024
Date data sharing statement initially provided
18/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising outcomes for people with knee pain through food: the FEAST randomised controlled trial
Scientific title
The effect of an anti-inflammatory dietary program compared to standard healthy eating education on clinical and biochemical outcomes of knee osteoarthritis: The FEAST (eFfect of an Anti-inflammatory diet for knee oSTeoarthritis) randomised controlled trial
Secondary ID [1] 306264 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FEAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 325014 0
Condition category
Condition code
Musculoskeletal 322453 322453 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive six individual consultations with a dietitian over 12 weeks to help them follow an anti-inflammatory eating program. The first consultation with the dietitian will be face-to-face for approximately 45 mins immediately after baseline assessment, with follow-up consultations of approximately 30 mins conducted over the phone/online. Follow-up consultations are recommended to occur in weeks 2, 4, 6, 9 and 12 but timing will be individualised as required. Anti-inflammatory dietary advice and education will emphasise the consumption of low-sugar fruits, non-starchy vegetables, fish, meat, eggs, dairy, nuts, seeds, and extra virgin olive oil. Participants will be encouraged to avoid highly processed food products, refined carbohydrates, high-sugar fruits, starchy vegetables, added sugar and processed meats.

During the initial consultation, dietitians will work closely with the participant to complete a detailed nutrition assessment and develop an individualised plan based on the participant’s situation and preferences focusing on anti-inflammatory diet principles. Dietitians will also provide a comprehensive explanation of the anti-inflammatory eating pattern and its potential benefits, address questions and/or concerns, and devise a personalised plan for the follow-up consultations. Participants will be provided with a suite of resources designed specifically for the study to support them throughout the intervention period, including a study booklet containing key principles of anti-inflammatory diets, anti-inflammatory food guides and a 4-week example meal plan, together with access to an anti-inflammatory eating program support app (Defeat Diabetes: https://www.defeatdiabetes.com.au/).

During follow-up consultations, dietitians will monitor progress and adherence to the anti-inflammatory program and provide further support, education, motivation and techniques to develop self-efficacy, which will be personalised using feedback from each participant and information regarding their eating pattern from a recently completed 3-day food diary.
Intervention code [1] 322686 0
Treatment: Other
Comparator / control treatment
Participants will receive two individual consultations with a dietitian over 12 weeks to provide advice and education regarding healthy eating based on the Australian Dietary Guidelines (https://www.eatforhealth.gov.au/). Two consultations represent usual care for patients referred for dietary management in Australia. The first consultation with the dietitian will be face-to-face for approximately 45 mins immediately after baseline assessment, with the follow-up consultation of approximately 30 mins conducted over the phone/online at approximately 6 weeks (timing will be individualised as required). Participants will be provided with an educational booklet designed specifically for the study emphasising the Australian Dietary Guideline principles and informed of the publicly available online resources from the Eat for Health website (emphasising low-fat foods). The principles focus on consumption of foods from the five food groups, while limiting intake of foods containing saturated fat, added salt, added sugars and alcohol.

At the follow-up consultation, the dietitian will provide additional education and advice on portion sizes or tips on reading food labels, depending on participants’ needs and interests, and address questions or concerns.
Control group
Active

Outcomes
Primary outcome [1] 330234 0
KOOS4: the average score 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] 330234 0
Change from baseline to 12 weeks
Secondary outcome [1] 405381 0
KOOS4 : the average score 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] 405381 0
Change from baseline to 26 weeks
Secondary outcome [2] 406326 0
KOOS-pain
Timepoint [2] 406326 0
Change from baseline to 12 and 26 weeks
Secondary outcome [3] 406327 0
KOOS-symptoms
Timepoint [3] 406327 0
Change from baseline to 12 and 26 weeks
Secondary outcome [4] 406328 0
KOOS-activities of daily living
Timepoint [4] 406328 0
Change from baseline to 12 and 26 weeks
Secondary outcome [5] 406329 0
KOOS-Sport and Recreation
Timepoint [5] 406329 0
Change from baseline to 12 and 26 weeks
Secondary outcome [6] 406330 0
KOOS-quality of life
Timepoint [6] 406330 0
Change from baseline to 12 and 26 weeks
Secondary outcome [7] 406331 0
Global rating of change (GROC) on a seven- point Likert scale (from much worse to much better).
Timepoint [7] 406331 0
Change from baseline to 12 and 26 weeks
Secondary outcome [8] 406333 0
Participant perception of achievement of acceptable symptoms: Patient acceptable symptom state (PASS)
Timepoint [8] 406333 0
Change from baseline to 12 and 26 weeks
Secondary outcome [9] 406334 0
Euro Qol 5D (EQ-5D)
Timepoint [9] 406334 0
Change from baseline to 12 and 26 weeks
Secondary outcome [10] 406335 0
Average knee pain during last week on 100mm visual analogue scale
Timepoint [10] 406335 0
Change from baseline to 12 and 26 weeks
Secondary outcome [11] 406336 0
Worst knee pain during past week on 100mm visual analogue scale
Timepoint [11] 406336 0
Change from baseline to 12 and 26 weeks
Secondary outcome [12] 406337 0
Other treatment received for knee pain (analgesic medication use and other healthcare use)
Timepoint [12] 406337 0
Change from baseline to 12 and 26 weeks
Secondary outcome [13] 406338 0
Brief Pain Inventory: assesses severity of pain and the degree to which pain interferes with common dimensions of feeling and function
Timepoint [13] 406338 0
Change from baseline to 12 and 26 weeks
Secondary outcome [14] 406339 0
International Physical Activity Questionnaire (IPAQ)
Timepoint [14] 406339 0
Change from baseline to 12 and 26 weeks
Secondary outcome [15] 406340 0
Self-perceived hunger on 100mm visual analogue scale
Timepoint [15] 406340 0
Change from baseline to 12 and 26 weeks
Secondary outcome [16] 406341 0
Self-perceived fatigue on 100mm visual analogue scale
Timepoint [16] 406341 0
Change from baseline to 12 and 26 weeks
Secondary outcome [17] 406342 0
Self-perceived energy on 100mm visual analogue scale
Timepoint [17] 406342 0
Change from baseline to 12 and 26 weeks
Secondary outcome [18] 406343 0
Blood pressure - assessed via an automated BP machine with inflatable cuff applied to the upper portion of the arm. Three measures will be taken a minimum of 1 minute apart
Timepoint [18] 406343 0
Change from baseline to 12 and 26 weeks
Secondary outcome [19] 407324 0
Body mass - assessed with standardised scales
Timepoint [19] 407324 0
Change from baseline to 12 and 26 weeks
Secondary outcome [20] 407325 0
Waist girth - assessed with tape measure
Timepoint [20] 407325 0
Change from baseline to 12 and 26 weeks
Secondary outcome [21] 407326 0
30 second chair stand test - the number of stands from a chair possible within 30 seconds
Timepoint [21] 407326 0
Change from baseline to 12 and 26 weeks
Secondary outcome [22] 407327 0
40metre walk test - the time taken to walk 40 metres
Timepoint [22] 407327 0
Change from baseline to 12 and 26 weeks
Secondary outcome [23] 407328 0
Body composition- dual-energy X-ray absorptiometry (DEXA) whole body scan
Timepoint [23] 407328 0
Change from baseline to 12 and 26 weeks
Secondary outcome [24] 407329 0
Cytokine IL-1ß - analysed from samples of blood collected via venepuncture
Timepoint [24] 407329 0
Change from baseline to 12 and 26 weeks
Secondary outcome [25] 407330 0
Cytokine IL-6 - analysed from samples of blood collected via venepuncture
Timepoint [25] 407330 0
Change from baseline to 12 and 26 weeks
Secondary outcome [26] 407331 0
Cytokine IL-8 - analysed from samples of blood collected via venepuncture
Timepoint [26] 407331 0
Change from baseline to 12 and 26 weeks
Secondary outcome [27] 407332 0
Cytokine IL-10 - analysed from samples of blood collected via venepuncture
Timepoint [27] 407332 0
Change from baseline to 12 and 26 weeks
Secondary outcome [28] 407333 0
Cytokine TNF-a - analysed from samples of blood collected via venepuncture
Timepoint [28] 407333 0
Change from baseline to 12 and 26 weeks
Secondary outcome [29] 407334 0
Blood glucose - analysed from samples of blood collected via venepuncture
Timepoint [29] 407334 0
Change from baseline to 12 and 26 weeks
Secondary outcome [30] 407335 0
HbA1c - analysed from samples of blood collected via venepuncture
Timepoint [30] 407335 0
Change from baseline to 12 and 26 weeks
Secondary outcome [31] 407336 0
Serum insulin
Timepoint [31] 407336 0
Change from baseline to 12 and 26 weeks
Secondary outcome [32] 407337 0
Liver function tests (incl. albumin) - analysed from samples of blood collected via venepuncture
Timepoint [32] 407337 0
Change from baseline to 12 and 26 weeks
Secondary outcome [33] 407339 0
HsCRP - analysed from samples of blood collected via venepuncture
Timepoint [33] 407339 0
Change from baseline to 12 and 26 weeks
Secondary outcome [34] 407340 0
Lipids (incl. HDL, triglycerides - analysed from samples of blood collected via venepuncture
Timepoint [34] 407340 0
Change from baseline to 12 and 26 weeks
Secondary outcome [35] 407341 0
Three-day food intake (total energy intake, macronutrients, micronutrients) - assessed using 3-day food diaries completed by participants and analysed using FoodWorks v10 Xyris Software
Timepoint [35] 407341 0
Change from baseline to 12 and 26 weeks
Secondary outcome [36] 407342 0
Dietary Inflammatory Index
Timepoint [36] 407342 0
Change from baseline to 12 and 26 weeks

Eligibility
Key inclusion criteria
Aged 45-85 years
Knee pain on most days of the past month
Knee pain for at least 3 months
Average knee pain during weight-bearing activities in the last week of at least 4/10 on numerical rating scale
No morning knee stiffness, or morning stiffness that lasts <30mins in the past week
Be willing to attend 3-4 phone consults and in-person 12- and 26-week follow-up
Minimum age
45 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)
Planning to have knee surgery in next six months
Already strictly following an anti-inflammatory diet (e.g., low carbohydrate, high-fat, paleo, Mediterranean)
Following a habitual diet that excludes animal products (e.g., Vegan diet)
Unable to follow anti-inflammatory diet (e.g., medically contraindicated, history of food allergy/hypersensitivity, family reasons)
Contraindications for DEXA scans (e.g., pregnant or breastfeeding (or planning pregnancy in next 6 months), >200kg body weight (due to DEXA limits))
>5kg weight fluctuation in past three months (i.e., unstable weight)
Unable to understand written and spoken English
Knee injection, injury or surgery in the past 3 months
A diagnosed psychiatric disorder (excluding anxiety and depression)
History of eating disorder or bariatric surgery
Taking the following diabetic medication that affects blood sugar levels (i.e., insulin, SGLT 2 inhibitors, sulfonylureas) to mitigate the risk of hypoglycaemia/ketoacidosis
Had all eligible knee joints replaced by arthroplasty

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)
Central independent randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation schedule will be developed by an independent statistician (concealed allocation) and will include random permuted blocks, stratified by sex and body mass index (above and below 30kg.m-2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Prospective Randomised Open-label Blinded-Endpoint (PROBE) superiority clinical trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All outcomes and analyses are prospectively categorised as primary, secondary or exploratory. Differences in all endpoints between the two arms of the study will be tested independently at the two-tailed 0.05 level of significance. All estimates of treatment effects will be presented with 95% confidence intervals. No formal adjustments will be undertaken to constrain the overall type I error associated with the secondary and exploratory analyses. Their purpose is to supplement evidence from the primary analysis to more fully characterise the treatment effect. Results from the secondary analyses will be interpreted in this context. Descriptive statistics will be generated for each of measure.

For the primary hypothesis, generalised linear models (with baseline value, sex and BMI (greater than or equal to 30 vs <30kg.m-2) as covariates and treatment condition as fixed factors) will be used to evaluate the treatment effect on KOOS4 at 12 weeks. A generalised linear mixed model (GLMM) utilising repeated measures at all time-points (for 26-week secondary hypotheses) will allow non-biased estimates of treatment effect in the presence of any potential missing cases, providing data are missing at random. A sensitivity analysis using pattern-mixture model to investigate the deviation from the missingness-at-random assumption will be carried out. For secondary binary outcomes (e.g., treatment success), mixed-effect logistic regression models will be used to assess the effect of treatment. All randomised participants will be included in the analysis as per the estimand framework (using while on treatment strategy) by a statistician blinded to group allocation. A subsequent analysis of participants classified as adherent to the protocol will be performed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/05/2022
Actual
31/08/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
107
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310616 0
Self funded/Unfunded
Name [1] 310616 0
Peter Brukner
Country [1] 310616 0
Australia
Funding source category [2] 310991 0
Government body
Name [2] 310991 0
National Health and Medical Research Council
Country [2] 310991 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country
Australia
Secondary sponsor category [1] 312292 0
None
Name [1] 312292 0
Address [1] 312292 0
Country [1] 312292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310220 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 310220 0
Ethics committee country [1] 310220 0
Australia
Date submitted for ethics approval [1] 310220 0
11/03/2022
Approval date [1] 310220 0
20/06/2022
Ethics approval number [1] 310220 0
HEC22044

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

Contacts
Principal investigator
Name 116894 0
Dr Adam Culvenor
Address 116894 0
La Trobe Sport and Exercise Medicine Research Centre
Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086
Country 116894 0
Australia
Phone 116894 0
+61 3 9479 5116
Fax 116894 0
Email 116894 0
[email protected]
Contact person for public queries
Name 116895 0
Adam Culvenor
Address 116895 0
La Trobe Sport and Exercise Medicine Research Centre, 58 Hume Street, Greensborough VIC 3088
Country 116895 0
Australia
Phone 116895 0
+61 3 9479 5116
Fax 116895 0
Email 116895 0
[email protected]
Contact person for scientific queries
Name 116896 0
Adam Culvenor
Address 116896 0
La Trobe Sport and Exercise Medicine Research Centre, 58 Hume Street, Greensborough VIC 3088
Country 116896 0
Australia
Phone 116896 0
+61 3 9479 5116
Fax 116896 0
Email 116896 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
For ethical reasons, individual data will not be publicly available.


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
No additional documents have been identified.