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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Synergy1
Equicaloric dose of maltodextrin
University of Calgary
Calgary, Alberta, Canada
Change in 30 second chair stand test
30 second chair stand test
Time frame: Baseline and 6 months
Change in 40 metre fast based walk
40 metre fast based walk
Time frame: Baseline and 6 months
Change in Time up and go test
Time up and go test
Time frame: Baseline and 6 months
Change in 6 minute walk test
6 minute walk test
Time frame: Baseline and 6 months
Change in knee function
Knee extensor torque isokinetic dynamometer (Biodex System3)
Time frame: Baseline and 6 months
Change in knee pain
Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale)
Time frame: 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).)
Time frame: Baseline and 6 months
Change in pain medication use
Pain medication questionnaire
Time frame: Baseline and 6 months
Change in body fat
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Body fat percent
Time frame: Baseline and 6 months
Change in fecal microbiota composition
Fecal microbiota
Time frame: Baseline and 6 months
Change in fecal short chain fatty acids (SCFA) concentration
Fecal SCFA
Time frame: Baseline and 6 months
Change in serum endotoxin
Serum LPS
Time frame: Baseline and 6 months
Change in serum inflammatory marker
Serum IL-6
Time frame: Baseline and 6 months
Change in physical activity level
ActiGraph Link® accelerometer
Time frame: Baseline and 6 months
Change in quality of life ratings
SF-36 Quality of Life Questionnaire
Time frame: Baseline and 6 months
Change in serum metabolomics
Serum LC-Qtof-Mass Spec metabolomics
Time frame: Baseline and 6 months