NCT05670314: INSPIRE

lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)

Completed NA Results posted Last updated 16 September 2025

What this trial tests

NA trial testing Inulin Fibre supplement in Osteoarthritis, Knee in 117 participants. Completed in 25 February 2025.

Timeline

1 May 2022

Primary endpoint
25 February 2025

25 February 2025

Quick facts

Lead sponsor	University of Nottingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	117
Start date	1 May 2022
Primary completion	25 February 2025
Estimated completion	25 February 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• Inulin Fibre supplement
• Maltodextrin (Placebo) — full drug profile →
• Exercise

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

University of Nottingham

Who can join

19 and older, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Numerical Rate Score (NRS) for Pain Primary · Baseline and 6 weeks

The Numerical Rate Score (NRS) will be used to assess the changes in the level of pain in response to the intervention between baseline and follow-up. Participants reported their pain on a scale ranging from 0 to 10, where 0 represents no pain and 10 the worst pain imaginable.

Group	Value	95% CI
Placebo Arm	0.67	± 2.49
Diet Only Arm	-0.73	± 2.32
Exercise Only Arm	-1.25	± 2.69
Diet + Exercise Intervention Arm	-1.21	± 1.76

Change in Functional Outcome 30-seconds Sit-to-stand (30CST) Secondary · Baseline and 6 weeks

Measures how many times a participant can rise from a chair to a full standing position in 30 seconds.

Group	Value	95% CI
Placebo Arm	1.23	± 1.67
Diet Only Arm	2.12	± 3.02
Exercise Only Arm	2.54	± 3.38
Diet + Exercise Intervention Arm	3.21	± 5.37

Change in Functional Outcome Timed-up and go (TUG) Secondary · Baseline and 6 weeks

Time in seconds to stand up, walk 3m, return, and sit. Average of 3 trials at baseline and follow-up (at the end of 6 weeks).

Group	Value	95% CI
Placebo Arm	-0.43	± 1.06
Diet Only Arm	-1.19	± 2.19
Exercise Only Arm	-2.07	± 5.82
Diet + Exercise Intervention Arm	-0.78	± 1.14

Change in Functional Outcome Grip Strength Secondary · Baseline and 6 weeks

Measured with dynamometer; average of 3 trials on dominant hand in seated position with participant applying as much grip pressure as possible on the dynamometer. The maximum reading (kg) in taken for each repetition.

Group	Value	95% CI
Placebo Arm	-1.43	± 6.44
Diet Only Arm	0.76	± 3.42
Exercise Only Arm	0.02	± 5.62
Diet + Exercise Intervention Arm	0.76	± 3.42

Change in Pain Sensitisation Outcome Temporal Summation (TS) Secondary · Baseline and 6 weeks

Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality temporal summation (TS). TS assesses sensitivity to sharpness by applying a brief "pinprick" stimulus (256 mN Pinprick; MRC-Systems, Heidelberg, Germany) to the skin with higher ratings potentially suggesting increased spinal cord pain sensitivity. A single stimulus was applied to the rectus

Group	Value	95% CI
Placebo Arm	0.30	± 1.66
Diet Only Arm	-0.20	± 1.52
Exercise Only Arm	-0.17	± 1.62
Diet + Exercise Intervention Arm	-0.63	± 2.01

Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superolateral Patella Site Secondary · Baseline and 6 weeks

Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: quadricep (2cm above superolateral edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most p

Group	Value	95% CI
Placebo Arm	-87.19	± 103.53
Diet Only Arm	-29.89	± 175.35
Exercise Only Arm	-92.74	± 159.03
Diet + Exercise Intervention Arm	-39.22	± 240.27

Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superomedial Patella Site Secondary · Baseline and 6 weeks

Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: quadricep (2cm above superomedial edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on the most pa

Group	Value	95% CI
Placebo Arm	-46.73	± 137.77
Diet Only Arm	-25.33	± 122.58
Exercise Only Arm	-41.25	± 126.96
Diet + Exercise Intervention Arm	-22.28	± 131.10

Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Medial Joint Line Site Secondary · Baseline and 6 weeks

Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from abeline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at the anatomical position: medial joint line (3cm medially from medial edge of patella). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of 50 kPa/s on t

Group	Value	95% CI
Placebo Arm	-54.54	± 132.90
Diet Only Arm	-31.72	± 132.51
Exercise Only Arm	-10.91	± 149.56
Diet + Exercise Intervention Arm	-24.02	± 160.48

Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Tibialis Anterior Muscle Site Secondary · Baseline and 6 weeks

Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from at baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: tibialis anterior (5 cm distal and 1 cm lateral to the tibial tuberosity). PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-AlgoMed, Israel) at a rate of

Group	Value	95% CI
Placebo Arm	-47.36	± 160.31
Diet Only Arm	-17.57	± 161.22
Exercise Only Arm	-7.74	± 122.59
Diet + Exercise Intervention Arm	-20.66	± 180.73

Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Brachioradialis Muscle Site Secondary · Baseline and 6 weeks

Pain sensitisation will be measured using quantitative sensory testing (QST) to assess any changes in pain sensitisation indices from baseline to follow-up. QST is a non-invasive method to assess pain sensitivity using standardised stimuli like mechanical pressure or sharpness. We used the QST modality pressure pain detection threshold (PPT) at anatomical position: brachioradialis (5 cm medial and distal to the lateral epicondyle) on the arm opposite the painful knee. PPT measures the lowest pressure a participant perceives as painful while pressure is applied using a handheld probe (Medoc-Alg

Group	Value	95% CI
Placebo Arm	-27.77	± 107.82
Diet Only Arm	-69.33	± 119.04
Exercise Only Arm	-37.31	± 95.64
Diet + Exercise Intervention Arm	-25.75	± 150.32

Change in Short Chain Fatty Acid Butyric Acid Secondary · Baseline and 6 weeks

Change in serum levels of short-chain fatty acid (SCFA) butyric acid in response to the interventions. SCFA levels in serum will be measured using mass spectrometry.

Group	Value	95% CI
Placebo Arm	-36.67	± 1082.93
Diet Only Arm	345.61	± 434.30
Exercise Only Arm	-233.17	± 991.08
Diet + Exercise Intervention Arm	769.14	± 3413.58

Change in Short Chain Fatty Acid Acetic Acid Secondary · Baseline and 6 weeks

Change in serum levels of short-chain fatty acid (SCFA) acetic acid in response to theinterventions. SCFA levels in serum will be measured using mass spectrometry.

Group	Value	95% CI
Placebo Arm	-869.59	± 3744.05
Diet Only Arm	306.32	± 1406.99
Exercise Only Arm	-1081.01	± 3561.43
Diet + Exercise Intervention Arm	110.37	± 3334.09

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 through Day 42 (daily assessments, 7 days/week). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo Arm

Serious: 0/27 (0%)

Deaths: 0/27

Diet Only Arm

Serious: 0/26 (0%)

Deaths: 0/26

Exercise Only Arm

Serious: 0/40 (0%)

Deaths: 0/40

Diet + Exercise Intervention Arm

Serious: 0/24 (0%)

Deaths: 0/24

Other adverse events (1 terms — click to expand)

Reaction	System	Placebo Arm	Diet Only Arm	Exercise Only Arm	Diet + Exercise Interventi…
Wind and bloating	Gastrointestinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT05670314 adverse events section.

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exercise for osteoarthritis of the knee.
   Lawford BJ, Hall M, Hinman RS, Van der Esch M, et al · · 2024 · cited 37× · PMID 39625083 · DOI 10.1002/14651858.cd004376.pub4
2. Effect of Prebiotic Supplementation With and Without Physiotherapy on Pain and Pain Sensitivity in People with Knee Osteoarthritis
   Kouraki A, Franks S, Vijay A, Kurien T, et al · · 2026