None listed
Conditions
Brief summary
Osteoarthritis is the most common form of arthritis and is a leading cause of global disability. This study will evaluate the effects of two different nutrition programs in individuals with knee OA delivered over 12 weeks. We hypothesise that the anti-inflammatory dietary intervention will result in greater improvements in pain, function, quality of life, inflammatory biomarkers and body composition after 12 and 26 weeks compared to a standard care control group.
Interventions
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 d
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.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Healthy volunteers
No
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
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
Outcome results
None listed