Effect of Prebiotics on Function and Pain in Patients With Osteoarthritis and Obesity

Study Overview
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Brief Summary
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The purpose of the present study is to determine if prebiotic supplementation can, through changes in the intestinal gut microbiota, lead to improvements in knee function and physical performance and reduce knee pain in adults with obesity and idiopathic metabolic knee osteoarthritis. We hypothesize that prebiotics will reduce systemic and local (knee joint) inflammation, thus improving knee function, lower pain medication use, and enhance performance of daily life activities.

Detailed Description
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Primary outcome: 1. To determine the change in knee joint function and physical performance in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo. Secondary outcomes: To determine the change in knee pain in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo. To examine the change in body composition (fat mass and lean mass) in participants treated with oligofructose-enriched inulin or placebo. To evaluate the change in quality of life in participants treated with oligofructose-enriched inulin or placebo. To gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic OA through examination of gut microbiota composition and short-chain fatty acid concentrations. To gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic OA through examination of serum inflammatory and metabolomics markers.

Official Title
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Effect of Prebiotics on Function and Pain in Patients With Knee Osteoarthritis and Obesity

Conditions
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Osteo Arthritis Knee, Obesity

Intervention / Treatment
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* Dietary Supplement: Prebiotic oligofructose-enriched inulin
* Dietary Supplement: Placebo maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged 30-75 years of age. BMI greater than 30kg/m2. Diagnosis via x-ray of knee OA grade II and III (Kellgren and Lawrence). Exclusion Criteria: Knee OA resulting from a traumatic injury. Previous knee surgery. Concomitant use of any weight loss medication, previous bariatric or other intestinal surgery Presence of active infection, pregnancy or lactation. Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment. Antibiotic use within 3 months prior to enrollment Uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Two 3.3g doses/day (12 kcal/dose) of maltodextrin | Dietary Supplement: Placebo maltodextrin<br>* Equicaloric dose of maltodextrin<br>|
| Experimental: Prebiotic<br>Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin | Dietary Supplement: Prebiotic oligofructose-enriched inulin<br>* Synergy1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 30 second chair stand test | 30 second chair stand test | Baseline and 6 months | 
| Change in 40 metre fast based walk | 40 metre fast based walk | Baseline and 6 months | 
| Change in Time up and go test | Time up and go test | Baseline and 6 months | 
| Change in 6 minute walk test | 6 minute walk test | Baseline and 6 months | 
| Change in knee function | Knee extensor torque isokinetic dynamometer (Biodex System3) | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knee pain | Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale) | Baseline and 6 months | 
| Change in knee injury and osteoarthritis outcome score (KOOS) | KOOS questionnaire (42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).) | Baseline and 6 months | 
| Change in pain medication use | Pain medication questionnaire | Baseline and 6 months | 
| Change in body fat | Body fat percent | Baseline and 6 months | 
| Change in fecal microbiota composition | Fecal microbiota | Baseline and 6 months | 
| Change in fecal short chain fatty acids (SCFA) concentration | Fecal SCFA | Baseline and 6 months | 
| Change in serum endotoxin | Serum LPS | Baseline and 6 months | 
| Change in serum inflammatory marker | Serum IL-6 | Baseline and 6 months | 
| Change in physical activity level | ActiGraph Link® accelerometer | Baseline and 6 months | 
| Change in quality of life ratings | SF-36 Quality of Life Questionnaire | Baseline and 6 months | 
| Change in serum metabolomics | Serum LC-Qtof-Mass Spec metabolomics | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Gut microbiota, Prebiotic