search
Back to results

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

Primary Purpose

Osteo Arthritis Knee, Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prebiotic oligofructose-enriched inulin
Placebo maltodextrin
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Pain, Gut microbiota, Prebiotic

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Prebiotic

Arm Description

Two 3.3g doses/day (12 kcal/dose) of maltodextrin

Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin

Outcomes

Primary Outcome Measures

Change in 30 second chair stand test
30 second chair stand test
Change in 40 metre fast based walk
40 metre fast based walk
Change in Time up and go test
Time up and go test
Change in 6 minute walk test
6 minute walk test
Change in knee function
Knee extensor torque isokinetic dynamometer (Biodex System3)

Secondary Outcome Measures

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

Full Information

First Posted
November 13, 2019
Last Updated
October 31, 2022
Sponsor
University of Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT04172688
Brief Title
Effect of Prebiotics on Function and Pain in Patients With Osteoarthritis and Obesity
Official Title
Effect of Prebiotics on Function and Pain in Patients With Knee Osteoarthritis and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Obesity
Keywords
Pain, Gut microbiota, Prebiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two 3.3g doses/day (12 kcal/dose) of maltodextrin
Arm Title
Prebiotic
Arm Type
Experimental
Arm Description
Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic oligofructose-enriched inulin
Intervention Description
Synergy1
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo maltodextrin
Intervention Description
Equicaloric dose of maltodextrin
Primary Outcome Measure Information:
Title
Change in 30 second chair stand test
Description
30 second chair stand test
Time Frame
Baseline and 6 months
Title
Change in 40 metre fast based walk
Description
40 metre fast based walk
Time Frame
Baseline and 6 months
Title
Change in Time up and go test
Description
Time up and go test
Time Frame
Baseline and 6 months
Title
Change in 6 minute walk test
Description
6 minute walk test
Time Frame
Baseline and 6 months
Title
Change in knee function
Description
Knee extensor torque isokinetic dynamometer (Biodex System3)
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in knee pain
Description
Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale)
Time Frame
Baseline and 6 months
Title
Change in knee injury and osteoarthritis outcome score (KOOS)
Description
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).)
Time Frame
Baseline and 6 months
Title
Change in pain medication use
Description
Pain medication questionnaire
Time Frame
Baseline and 6 months
Title
Change in body fat
Description
Body fat percent
Time Frame
Baseline and 6 months
Title
Change in fecal microbiota composition
Description
Fecal microbiota
Time Frame
Baseline and 6 months
Title
Change in fecal short chain fatty acids (SCFA) concentration
Description
Fecal SCFA
Time Frame
Baseline and 6 months
Title
Change in serum endotoxin
Description
Serum LPS
Time Frame
Baseline and 6 months
Title
Change in serum inflammatory marker
Description
Serum IL-6
Time Frame
Baseline and 6 months
Title
Change in physical activity level
Description
ActiGraph Link® accelerometer
Time Frame
Baseline and 6 months
Title
Change in quality of life ratings
Description
SF-36 Quality of Life Questionnaire
Time Frame
Baseline and 6 months
Title
Change in serum metabolomics
Description
Serum LC-Qtof-Mass Spec metabolomics
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Change in gastrointestinal comfort
Description
Gastrointestinal Feelings Questionnaire
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raylene A Reimer, PhD, RD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33827639
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs