Effect of Prebiotics on Function and Pain in Patients with Osteoarthritis and Obesity
NCT ID: NCT04172688
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2018-11-18
2022-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Two 3.3g doses/day (12 kcal/dose) of maltodextrin
Placebo maltodextrin
Equicaloric dose of maltodextrin
Prebiotic
Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin
Prebiotic oligofructose-enriched inulin
Synergy1
Interventions
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Prebiotic oligofructose-enriched inulin
Synergy1
Placebo maltodextrin
Equicaloric dose of maltodextrin
Eligibility Criteria
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Inclusion Criteria
* BMI greater than 30kg/m2.
* Diagnosis via x-ray of knee OA grade II and III (Kellgren and Lawrence).
Exclusion Criteria
* 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.
30 Years
75 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Dr. Raylene Reimer
Professor
Principal Investigators
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Raylene A Reimer, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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References
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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.
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.
Other Identifiers
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REB17-2363
Identifier Type: -
Identifier Source: org_study_id