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Completed

NCT Number: NCT04172688

Effect of Prebiotics on Function and Pain in Patients with 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.

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Key information

Conditions

Osteo Arthritis Knee Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prebiotic oligofructose-enriched inulin

Dietary Supplement

Synergy1

Placebo Maltodextrin

Dietary Supplement

Equicaloric dose of maltodextrin

Primary outcomes

  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 outcomes

  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 outcomes

  1. Change in gastrointestinal comfort

    Time frame: Baseline and 6 months

    Gastrointestinal Feelings Questionnaire

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 21, 2019
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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