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

Sponsor

University of Calgary (Other)

Overall Status

Recruiting

CT.gov ID

NCT04172688

Collaborator

(none)

Enrollment

Location

Arms

60.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteo Arthritis Knee Obesity	Dietary Supplement: Prebiotic oligofructose-enriched inulin Dietary Supplement: Placebo maltodextrin	N/A

Detailed Description

Primary outcome:

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:

To determine the change in knee pain in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo.
To examine the change in body composition (fat mass and lean mass) in participants treated with oligofructose-enriched inulin or placebo.
To evaluate the change in quality of life in participants treated with oligofructose-enriched inulin or placebo.
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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 18, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in 30 second chair stand test [Baseline and 6 months]
30 second chair stand test
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
Change in knee function [Baseline and 6 months]
Knee extensor torque isokinetic dynamometer (Biodex System3)

Secondary Outcome Measures

Change in knee pain [Baseline and 6 months]
Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale)
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 pain medication use [Baseline and 6 months]
Pain medication questionnaire
Change in body fat [Baseline and 6 months]
Body fat percent
Change in fecal microbiota composition [Baseline and 6 months]
Fecal microbiota
Change in fecal short chain fatty acids (SCFA) concentration [Baseline and 6 months]
Fecal SCFA
Change in serum endotoxin [Baseline and 6 months]
Serum LPS
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 quality of life ratings [Baseline and 6 months]
SF-36 Quality of Life Questionnaire
Change in serum metabolomics [Baseline and 6 months]
Serum LC-Qtof-Mass Spec metabolomics

Other Outcome Measures

Change in gastrointestinal comfort [Baseline and 6 months]
Gastrointestinal Feelings Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.