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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Osteo Arthritis Knee
• Intervention / Treatment: Dietary supplement: Placebo maltodextrin; Dietary supplement: Prebiotic oligofructose-enriched inulin

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Two 3.3g doses/day (12 kcal/dose) of maltodextrin	Dietary supplement: Placebo maltodextrin; Equicaloric dose of maltodextrin
Experimental: Prebiotic; Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin	Dietary supplement: Prebiotic oligofructose-enriched inulin; Synergy1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gastrointestinal comfort	Gastrointestinal Feelings Questionnaire	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Raylene A Reimer, PhD, RD, University of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2018
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Prebiotic; Gut microbiota
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nutrition Disorders; Arthritis; Joint Diseases; Rheumatic Diseases; Overnutrition; Body Weight; Overweight; Obesity; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: REB17-2363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No