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

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee; Obesity
• Interventions: Dietary Supplement: Placebo maltodextrin; Dietary Supplement: Prebiotic oligofructose-enriched inulin

• Registration Number: NCT04172688
• Lead Sponsor: University of Calgary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-18
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Primary Completion: 2021-10-01
• Study Completion: 2022-10-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo maltodextrin	Two 3.3g doses/day (12 kcal/dose) of maltodextrin
Prebiotic	Prebiotic oligofructose-enriched inulin	Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin

Primary Outcome Measures

Name	Time	Method
Change in 30 second chair stand test	Baseline and 6 months	30 second chair stand test
Change in knee function	Baseline and 6 months	Knee extensor torque isokinetic dynamometer (Biodex System3)
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 Outcome Measures

Name	Time	Method
Change in serum metabolomics	Baseline and 6 months	Serum LC-Qtof-Mass Spec metabolomics
Change in knee pain	Baseline and 6 months	Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale)
Change in serum inflammatory marker	Baseline and 6 months	Serum IL-6
Change in physical activity level	Baseline and 6 months	ActiGraph Link® accelerometer
Change in body fat	Baseline and 6 months	Body fat percent
Change in fecal short chain fatty acids (SCFA) concentration	Baseline and 6 months	Fecal SCFA
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 fecal microbiota composition	Baseline and 6 months	Fecal microbiota
Change in serum endotoxin	Baseline and 6 months	Serum LPS
Change in quality of life ratings	Baseline and 6 months	SF-36 Quality of Life Questionnaire
Change in pain medication use	Baseline and 6 months	Pain medication questionnaire

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada