Clinical trial NCT05670314: lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)
Official title: Molecular Signatures of Endocannabinoid Induced Pain Relief in Humans: Lifestyle Interventions, Systemic and Localised Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Intervention model description: 2x2 intervention with 30 individuals per block: placebo, diet only, exercise only, diet + exercise
Primary purpose: BASIC_SCIENCE

Brief 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


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Numerical Rate Score (NRS) for pain
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Changes in serum Endocannabinoid levels
timeFrame: Baseline and 6 weeks
measure: Changes in serum Cytokines levels
timeFrame: Baseline and 6 weeks
measure: Changes in serum markers of immune phenotyping (PBMCs)
timeFrame: Baseline and 6 weeks
measure: Changes in gut microbiome composition and short chain fatty acids
timeFrame: Baseline and 6 weeks
measure: Changes in DNA methylation on a subset of individuals
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: Professor in Genetic and Molecular Epidemiology
name: Ana Valdes, PhD
role: PRINCIPAL_INVESTIGATOR
References: