lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)

Osteoarthritis, Knee Clinical Trial

— INSPIRE  

Official title:

Molecular Signatures of Endocannabinoid Induced Pain Relief in Humans: Lifestyle Interventions, Systemic and Localised Changes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670314
• Other study ID #: 473-0322
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2022
• Source: University of Nottingham
• Contact: Amrita Vijay, PhD
• Phone: +44 (0) 115 823 1754
• Email: amrita.vijay[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will be a placebo controlled randomised intervention study 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. The end-points of the study are non-clinical outcomes. N= 120. 2x2 intervention with 30 individuals per block: placebo, diet only, exercise only, diet + exercise

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Inulin Fibre supplement
20g/ day. Inulin is easily dissolvable in liquid and can be incorporated into the usual diet - by adding to water, juice, smoothies, cereal, yogurt etc.
• Maltodextrin (Placebo)
10g/ day which can be consumed by adding to breakfast cereal/ smoothie/ yogurt or drink of choice

Behavioral:
• Exercise
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.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Numerical Rate Score (NRS) for pain	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.	Baseline and 6 weeks
Secondary	Changes in serum Endocannabinoid levels	Serum levels of Endocannabinoids will be measured using mass spectrometry in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in levels of Endocannabinoids in response to the intervention.	Baseline and 6 weeks
Secondary	Changes in serum Cytokines levels	Serum levels of cytokines will be measured using ELISA in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in levels of pro and anti-inflammatory cytokines in response to the intervention.	Baseline and 6 weeks
Secondary	Changes in serum markers of immune phenotyping (PBMCs)	Serum levels of PBMCs will be measured using a multiplex technique in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in immunological function in response to the intervention.	Baseline and 6 weeks
Secondary	Changes in gut microbiome composition and short chain fatty acids	Changes in gut microbiome composition and serum levels of short-chain fatty acids (SCFAs) in response to the interventions. Gut microbiome composition will be measured using 16S sequencing on stool samples. SCFAs in serum will be measured using mass spectrometry.	Baseline and 6 weeks
Secondary	Changes in DNA methylation on a subset of individuals	DNA methylation will be measured using specialized ELISA kits in samples collected at baseline and at follow-up (at the end of six weeks).	Baseline and 6 weeks