The effect of an anti-­inflammatory diet on clinical and biochemical features of knee osteoarthritis: a pilot RCT

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Musculoskeletal - Osteoarthritis; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12620000229976
• Lead Sponsor: a Trobe University: Research Focus Area: Sport, Exercise and Rehabilitation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-25
• Study Completion: 2020-06-29
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pdateFeasibility 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: 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. ]