Clinical trial NCT04172688: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Obesity
Keywords: Pain
Gut microbiota
Prebiotic
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Change in 30 second chair stand test
timeFrame: Baseline and 6 months
measure: Change in 40 metre fast based walk
timeFrame: Baseline and 6 months
measure: Change in Time up and go test
timeFrame: Baseline and 6 months
measure: Change in 6 minute walk test
timeFrame: Baseline and 6 months
measure: Change in knee function
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in knee pain
timeFrame: Baseline and 6 months
measure: Change in knee injury and osteoarthritis outcome score (KOOS)
timeFrame: Baseline and 6 months
measure: Change in pain medication use
timeFrame: Baseline and 6 months
measure: Change in body fat
timeFrame: Baseline and 6 months
measure: Change in fecal microbiota composition
timeFrame: Baseline and 6 months
measure: Change in fecal short chain fatty acids (SCFA) concentration
timeFrame: Baseline and 6 months
measure: Change in serum endotoxin
timeFrame: Baseline and 6 months
measure: Change in serum inflammatory marker
timeFrame: Baseline and 6 months
measure: Change in physical activity level
timeFrame: Baseline and 6 months
measure: Change in quality of life ratings
timeFrame: Baseline and 6 months
measure: Change in serum metabolomics
timeFrame: Baseline and 6 months
Other outcomes:
measure: Change in gastrointestinal comfort
timeFrame: Baseline and 6 months
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Raylene A Reimer, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
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.