NCT04172688

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

Effect of Prebiotics on Function and Pain in Patients with Knee Osteoarthritis and Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteo Arthritis Knee
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic oligofructose-enriched inulin	Synergy1
DIETARY_SUPPLEMENT	Placebo maltodextrin	Equicaloric dose of maltodextrin

Timeline

• Start date: 2018-11-18
• Primary completion: 2021-10-01
• Completion: 2022-10-30
• First posted: 2019-11-21
• Last updated: 2024-12-05

Locations

1 site across 1 country: Canada