Obesity, Osteo Arthritis Knee
Conditions
Keywords
Pain, Gut microbiota, Prebiotic
Brief summary
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
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: 1. To determine the change in knee pain in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo. 2. To examine the change in body composition (fat mass and lean mass) in participants treated with oligofructose-enriched inulin or placebo. 3. To evaluate the change in quality of life in participants treated with oligofructose-enriched inulin or placebo. 4. 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. 5. To gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic OA through examination of serum inflammatory and metabolomics markers.
Interventions
DIETARY_SUPPLEMENTPrebiotic oligofructose-enriched inulin
Synergy1
DIETARY_SUPPLEMENTPlacebo maltodextrin
Equicaloric dose of maltodextrin
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in knee function | Baseline and 6 months | Knee extensor torque isokinetic dynamometer (Biodex System3) |
| Change in 30 second chair stand test | Baseline and 6 months | 30 second chair stand test |
| Change in 40 metre fast based walk | Baseline and 6 months | 40 metre fast based walk |
| Change in Time up and go test | Baseline and 6 months | Time up and go test |
| Change in 6 minute walk test | Baseline and 6 months | 6 minute walk test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal microbiota composition | Baseline and 6 months | Fecal microbiota |
| Change in fecal short chain fatty acids (SCFA) concentration | Baseline and 6 months | Fecal SCFA |
| Change in serum endotoxin | Baseline and 6 months | Serum LPS |
| Change in physical activity level | Baseline and 6 months | ActiGraph Link® accelerometer |
| Change in quality of life ratings | Baseline and 6 months | SF-36 Quality of Life Questionnaire |
| Change in serum metabolomics | Baseline and 6 months | Serum LC-Qtof-Mass Spec metabolomics |
| Change in serum inflammatory marker | Baseline and 6 months | Serum IL-6 |
| Change in knee pain | Baseline and 6 months | Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale) |
| Change in knee injury and osteoarthritis outcome score (KOOS) | Baseline and 6 months | 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).) |
| Change in pain medication use | Baseline and 6 months | Pain medication questionnaire |
| Change in body fat | Baseline and 6 months | Body fat percent |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in gastrointestinal comfort | Baseline and 6 months | Gastrointestinal Feelings Questionnaire |
Countries
Canada
Outcome results
None listed