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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Two 3.3g doses/day (12 kcal/dose) of maltodextrin |
|
| Prebiotic | Experimental | Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic oligofructose-enriched inulin | Dietary Supplement | Synergy1 |
| |
| 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 |
| 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).) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gastrointestinal comfort | Gastrointestinal Feelings Questionnaire | Baseline and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raylene A Reimer, PhD, RD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38713231 | Derived | Fortuna R, Wang W, Mayengbam S, Tuplin EWN, Sampsell K, Sharkey KA, Hart DA, Reimer RA. Effect of prebiotic fiber on physical function and gut microbiota in adults, mostly women, with knee osteoarthritis and obesity: a randomized controlled trial. Eur J Nutr. 2024 Sep;63(6):2149-2161. doi: 10.1007/s00394-024-03415-w. Epub 2024 May 7. | |
| 33827639 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo maltodextrin |
| Dietary Supplement |
Equicaloric dose of maltodextrin |
|
| 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 |
| Fortuna R, Hart DA, Sharkey KA, Schachar RA, Johnston K, Reimer RA. Effect of a prebiotic supplement on knee joint function, gut microbiota, and inflammation in adults with co-morbid obesity and knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2021 Apr 7;22(1):255. doi: 10.1186/s13063-021-05212-w. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |