Back to resultslIfestyle iNterventionS for PaIn ReliEf (INSPIRE) (INSPIRE)
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Inulin Fibre supplement
Maltodextrin (Placebo)
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis, Knee
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)
Sites / Locations
- University of NottinghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo arm
Diet only Arm
Exercise only arm
Diet + exercise intervention arm
Arm Description
The participants in the placebo/control arm (N=30) will be required to take 10g of maltodextrin for the same period of 6 weeks.
The participants in the dietary intervention arm will be required to take 20g of inulin (N=30) for a period of 6 weeks.
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.
The participants in this arm will be required to take 20g of inulin (N=30) for a period of 6 weeks and doing exercise at the same time.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT05670314
First Posted
November 18, 2022
Last Updated
December 20, 2022
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT05670314
Brief Title
lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)
Acronym
INSPIRE
Official Title
Molecular Signatures of Endocannabinoid Induced Pain Relief in Humans: Lifestyle Interventions, Systemic and Localised Changes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2x2 intervention with 30 individuals per block: placebo, diet only, exercise only, diet + exercise
Masking
ParticipantInvestigator
Masking Description
Randomisation will be performed using an online software (sealedenvelope.com). The inulin vs placebo allocation will be double blinded. The exercise part of the intervention will not be blinded
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
The participants in the placebo/control arm (N=30) will be required to take 10g of maltodextrin for the same period of 6 weeks.
Arm Title
Diet only Arm
Arm Type
Experimental
Arm Description
The participants in the dietary intervention arm will be required to take 20g of inulin (N=30) for a period of 6 weeks.
Arm Title
Exercise only arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Diet + exercise intervention arm
Arm Type
Experimental
Arm Description
The participants in this arm will be required to take 20g of inulin (N=30) for a period of 6 weeks and doing exercise at the same time.
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin Fibre supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin (Placebo)
Intervention Description
10g/ day which can be consumed by adding to breakfast cereal/ smoothie/ yogurt or drink of choice
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Numerical Rate Score (NRS) for pain
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Changes in serum Endocannabinoid levels
Description
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.
Time Frame
Baseline and 6 weeks
Title
Changes in serum Cytokines levels
Description
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.
Time Frame
Baseline and 6 weeks
Title
Changes in serum markers of immune phenotyping (PBMCs)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Changes in gut microbiome composition and short chain fatty acids
Description
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.
Time Frame
Baseline and 6 weeks
Title
Changes in DNA methylation on a subset of individuals
Description
DNA methylation will be measured using specialized ELISA kits in samples collected at baseline and at follow-up (at the end of six weeks).
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amrita Vijay, PhD
Phone
+44 (0) 115 823 1754
Email
amrita.vijay@nottingham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Valdes, PhD
Phone
+44 (0) 115 823 1754
Email
ana.valdes@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Valdes, PhD
Organizational Affiliation
Professor in Genetic and Molecular Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amrita Vijay, PhD
Phone
+44 (0) 115 823 1754
Email
amrita.vijay@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Ana Valdes, PhD
Phone
+44 (0) 115 823 1754
Email
ana.valdes@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Ana Valdes, PhD
First Name & Middle Initial & Last Name & Degree
Amrita Vijay, PhD
First Name & Middle Initial & Last Name & Degree
Moira Taylor, PhD
First Name & Middle Initial & Last Name & Degree
Stephan Kluzek, PhD
First Name & Middle Initial & Last Name & Degree
Benjamin Smith, PhD
First Name & Middle Initial & Last Name & Degree
Liz Simpson, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To comply with the data protection act, personal data will be deleted as soon as possible after it is no longer needed for the study.
Learn more about this trial
lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)
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