N/A
Completed N=117
lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT05670314 ↗
Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Change in Numerical Rate Score (NRS) for Pain — 0.67; -0.73; -1.25; -1.21 units on a scale
Summary
This is a 2x2 factorial design randomised controlled trial in which participants with knee pain will be grouped into the diet intervention, exercise intervention, diet and exercise intervention or placebo arm. The study involves intake of dietary supplements and performing routine exercises which are commonly used and are not pharmacological agents. N= 117. 2x2 intervention with individuals per block: placebo (n=27), diet only (n=26), exercise only (n=40), diet + exercise (n=24)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Numerical Rate Score (NRS) for Pain |
0.67; -0.73; -1.25; -1.21 | — |
| SECONDARY Change in Functional Outcome 30-seconds Sit-to-stand (30CST) |
1.23; 2.12; 2.54; 3.21 | — |
| SECONDARY Change in Functional Outcome Timed-up and go (TUG) |
-0.43; -1.19; -2.07; -0.78 | — |
| SECONDARY Change in Functional Outcome Grip Strength |
-1.43; 0.76; 0.02; 0.76 | — |
| SECONDARY Change in Pain Sensitisation Outcome Temporal Summation (TS) |
0.30; -0.20; -0.17; -0.63 | — |
| SECONDARY Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superolateral Patella Site |
-87.19; -29.89; -92.74; -39.22 | — |
| SECONDARY Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superomedial Patella Site |
-46.73; -25.33; -41.25; -22.28 | — |
| SECONDARY Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Medial Joint Line Site |
-54.54; -31.72; -10.91; -24.02 | — |
| SECONDARY Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Tibialis Anterior Muscle Site |
-47.36; -17.57; -7.74; -20.66 | — |
| SECONDARY Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Brachioradialis Muscle Site |
-27.77; -69.33; -37.31; -25.75 | — |
| SECONDARY Change in Short Chain Fatty Acid Butyric Acid |
-36.67; 345.61; -233.17; 769.14 | — |
| SECONDARY Change in Short Chain Fatty Acid Acetic Acid |
-869.59; 306.32; -1081.01; 110.37 | — |
| SECONDARY Change in Inflammatory Protein Interleukin-6 (IL-6) Levels |
-1.85; -0.70; -0.25; -0.12 | — |
| SECONDARY Change in Tumor Necrosis Factor (TNF) Inflammatory Protein Levels |
-0.52; -0.72; -0.39; -0.34 | — |
| SECONDARY Change in Inflammatory Protein Interferon Gamma (IFN-γ) Levels |
0.32; 0.04; -0.72; -0.36 | — |
| SECONDARY Changes in Gut Microbiome (Shannon Diversity Index) |
0.01; -0.07; -0.09; -0.08 | — |
| SECONDARY Change in Serum Endocannabinoid Anandamide (AEA) Levels |
0.32; 0.05; 0.05; 0.31 | — |
| SECONDARY Change in Serum 2-arachidonoylglycerol (2-AG) Endocannabinoid Levels |
35.45; 6.28; 37.58; 16.83 | — |
| SECONDARY Changes in Calcium Voltage-gated Channel Subunit alpha1 B Gene Expression Levels Using Transcriptomics on a Subset of Individuals |
26.37; 49.50 | — |
| SECONDARY Changes in Solute Carrier Family 12 Member 5 Gene Expression Levels Using Transcriptomics on a Subset of Individuals |
14.02; 20.75 | — |
| SECONDARY Changes in Sodium Voltage-gated Channel Alpha Subunit 11 Gene Expression Levels Using Transcriptomics on a Subset of Individuals |
12.26; 31.97 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with any pain in or around a knee on most days for more than 3 months
- Participant is willing and able to give informed consent for participation in the study
- Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2
Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
- Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
- Are taking the following medications: immunosuppressants, anticoagulants, amiodarone and/or perhexiline
- Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
- Pregnant or breast feeding
- History or current psychiatric illness
- History or current neurological condition (e.g. epilepsy)
- Those undergoing revision, having severe hip OA, inflammatory arthropathies
- Diagnosed non-OA cause of knee pain (e.g. rheumatoid arthritis)
- Neuropathy or diabetes mellitus
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (this must remain for ALL UoN FMHS UREC approved studies)
Data sourced from ClinicalTrials.gov (NCT05670314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.