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

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ClinicalTrials.gov Identifier: NCT04172688
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Raylene Reimer, University of Calgary

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 18, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in 30 second chair stand test [ Time Frame: Baseline and 6 months ]
    30 second chair stand test

  2. Change in 40 metre fast based walk [ Time Frame: Baseline and 6 months ]
    40 metre fast based walk

  3. Change in Time up and go test [ Time Frame: Baseline and 6 months ]
    Time up and go test

  4. Change in 6 minute walk test [ Time Frame: Baseline and 6 months ]
    6 minute walk test

  5. Change in knee function [ Time Frame: Baseline and 6 months ]
    Knee extensor torque isokinetic dynamometer (Biodex System3)


Secondary Outcome Measures :
  1. Change in knee pain [ Time Frame: Baseline and 6 months ]
    Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale)

  2. Change in knee injury and osteoarthritis outcome score (KOOS) [ Time Frame: 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).)

  3. Change in pain medication use [ Time Frame: Baseline and 6 months ]
    Pain medication questionnaire

  4. Change in body fat [ Time Frame: Baseline and 6 months ]
    Body fat percent

  5. Change in fecal microbiota composition [ Time Frame: Baseline and 6 months ]
    Fecal microbiota

  6. Change in fecal short chain fatty acids (SCFA) concentration [ Time Frame: Baseline and 6 months ]
    Fecal SCFA

  7. Change in serum endotoxin [ Time Frame: Baseline and 6 months ]
    Serum LPS

  8. Change in serum inflammatory marker [ Time Frame: Baseline and 6 months ]
    Serum IL-6

  9. Change in physical activity level [ Time Frame: Baseline and 6 months ]
    ActiGraph Link® accelerometer

  10. Change in quality of life ratings [ Time Frame: Baseline and 6 months ]
    SF-36 Quality of Life Questionnaire

  11. Change in serum metabolomics [ Time Frame: Baseline and 6 months ]
    Serum LC-Qtof-Mass Spec metabolomics


Other Outcome Measures:
  1. Change in gastrointestinal comfort [ Time Frame: Baseline and 6 months ]
    Gastrointestinal Feelings Questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04172688


Contacts
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Contact: Raylene A Reimer, PhD, RD 403-220-8218 reimer@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Raylene A Reimer, PhD, RD    403-220-8218    reimer@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Raylene A Reimer, PhD, RD University of Calgary
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Raylene Reimer, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT04172688    
Other Study ID Numbers: REB17-2363
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Raylene Reimer, University of Calgary:
Pain
Gut microbiota
Prebiotic
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Obesity
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases