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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172688
• Other study ID #: REB17-2363
• Status: Completed
• Phase: N/A
• Start date: November 18, 2018
• Est. completion date: October 30, 2022

Study information

• Verified date: October 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 30, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Prebiotic oligofructose-enriched inulin
Synergy1
• Placebo maltodextrin
Equicaloric dose of maltodextrin

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in gastrointestinal comfort	Gastrointestinal Feelings Questionnaire	Baseline and 6 months
Primary	Change in 30 second chair stand test	30 second chair stand test	Baseline and 6 months
Primary	Change in 40 metre fast based walk	40 metre fast based walk	Baseline and 6 months
Primary	Change in Time up and go test	Time up and go test	Baseline and 6 months
Primary	Change in 6 minute walk test	6 minute walk test	Baseline and 6 months
Primary	Change in knee function	Knee extensor torque isokinetic dynamometer (Biodex System3)	Baseline and 6 months
Secondary	Change in knee pain	Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale)	Baseline and 6 months
Secondary	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).)	Baseline and 6 months
Secondary	Change in pain medication use	Pain medication questionnaire	Baseline and 6 months
Secondary	Change in body fat	Body fat percent	Baseline and 6 months
Secondary	Change in fecal microbiota composition	Fecal microbiota	Baseline and 6 months
Secondary	Change in fecal short chain fatty acids (SCFA) concentration	Fecal SCFA	Baseline and 6 months
Secondary	Change in serum endotoxin	Serum LPS	Baseline and 6 months
Secondary	Change in serum inflammatory marker	Serum IL-6	Baseline and 6 months
Secondary	Change in physical activity level	ActiGraph Link® accelerometer	Baseline and 6 months
Secondary	Change in quality of life ratings	SF-36 Quality of Life Questionnaire	Baseline and 6 months
Secondary	Change in serum metabolomics	Serum LC-Qtof-Mass Spec metabolomics	Baseline and 6 months