lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)
Key facts
- Who runs it
- University of Nottingham
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 117 people enrolled
- Started
- 1 May 2022
- Ended
- 25 Feb 2025
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Inulin Fibre supplement
- Maltodextrin (Placebo)
- Exercise
- Record updated
- 16 September 2025
Who can take part
- Age
- 19 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Are taking the following medications: immunosuppressants, anticoagulants, amiodarone and/or perhexiline
- Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
- History or current psychiatric illness
- History or current neurological condition (e.g. epilepsy)
- Neuropathy or diabetes mellitus
- The participant may not enter the study if ANY of the following apply:
- Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
- Pregnant or breast feeding
- Those undergoing revision, having severe hip OA, inflammatory arthropathies
- Diagnosed non-OA cause of knee pain (e.g. rheumatoid arthritis)
- 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)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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)
The 4 groups in the trial
- Placebo armPlacebo, for comparison
The participants in the placebo/control arm will be required to take 10g of maltodextrin for the same period of 6 weeks.
Treatment: Maltodextrin (Placebo)
- Diet only ArmTreatment being tested
The participants in the dietary intervention arm will be required to take 20g of inulin for a period of 6 weeks.
Treatment: Inulin Fibre supplement
- Exercise only armTreatment being tested
Joint Academy An app-based exercises platform (Joint Academy®) will be used as an intervention given to the treatment arm. The programme consists of a mixture of open and close chain exercises, a combination of concentric, eccentric and focusing on the global strength of legs including the muscles around the hips and knee joints as well as balance enhancement exercises. The intervention also includes educational sessions integrated into the programme covering the basics of OA, its treatment, self-managing symptoms of OA and the benefits of maintaining a healthy lifestyle. The exercise intervention focuses on core stability and performance, neuromuscular leg strengthening and balance enhancement.
Treatment: Exercise
- Diet + exercise intervention armTreatment being tested
The participants in this arm will be required to take 20g of inulin for a period of 6 weeks and doing exercise at the same time.
Treatment: Inulin Fibre supplement and Exercise
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Molecular Signatures of Endocannabinoid Induced Pain Relief in Humans: Lifestyle Interventions, Systemic and Localised Changes
- Record updated
- 16 September 2025