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

University of Calgary

Status

Completed

Conditions

Obesity

Osteo Arthritis Knee

Treatments

Dietary Supplement: Prebiotic oligofructose-enriched inulin

Dietary Supplement: Placebo maltodextrin

Study type

Interventional

Funder types

Other

Identifiers

NCT04172688

REB17-2363

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No 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.