Osteo Arthritis KneeNCT04172688
Effect of Prebiotics on Function and Pain in Patients with Osteoarthritis and Obesity
A study testing Prebiotic oligofructose-enriched inulin in people with Osteo Arthritis Knee and Obesity, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee, Obesity
- What is being tested?
- Prebiotic oligofructose-enriched inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 18 Nov 2018to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prebiotics on Function and Pain in Patients with Knee 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.
Read the detailed 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.
- Conditions
- Osteo Arthritis Knee, Obesity
- Being tested
- Prebiotic oligofructose-enriched inulin, Placebo maltodextrin
- Keywords
- Pain, Gut microbiota, Prebiotic
- Medical subject headings
- Obesity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic oligofructose-enriched inulinDietary supplement
Synergy1
Placebo maltodextrinDietary supplement
Equicaloric dose of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two 3.3g doses/day (12 kcal/dose) of maltodextrin Receives: Dietary Supplement: Placebo maltodextrin |
| Prebiotic | Experimental | Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin Receives: Dietary Supplement: Prebiotic oligofructose-enriched inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 30 second chair stand test
30 second chair stand test
Measured: Baseline and 6 months
Change in 40 metre fast based walk
40 metre fast based walk
Measured: Baseline and 6 months
Change in Time up and go test
Time up and go test
Measured: Baseline and 6 months
Change in 6 minute walk test
6 minute walk test
Measured: Baseline and 6 months
Change in knee function
Knee extensor torque isokinetic dynamometer (Biodex System3)
Measured: Baseline and 6 months
Secondary outcomes (11)
Change in knee pain
Numerical Pain Rating Scale (NPRS) for Knee Pain (0-10 scale)
Measured: Baseline and 6 months
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).)
Measured: Baseline and 6 months
Change in pain medication use
Pain medication questionnaire
Measured: Baseline and 6 months
Change in body fat
Body fat percent
Measured: Baseline and 6 months
Change in fecal microbiota composition
Fecal microbiota
Measured: Baseline and 6 months
Change in fecal short chain fatty acids (SCFA) concentration
Fecal SCFA
Measured: Baseline and 6 months
Change in serum endotoxin
Serum LPS
Measured: Baseline and 6 months
Change in serum inflammatory marker
Serum IL-6
Measured: Baseline and 6 months
Change in physical activity level
ActiGraph Link® accelerometer
Measured: Baseline and 6 months
Change in quality of life ratings
SF-36 Quality of Life Questionnaire
Measured: Baseline and 6 months
Change in serum metabolomics
Serum LC-Qtof-Mass Spec metabolomics
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start18 Nov 2018
- Primary completion1 Oct 2021
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Raylene Reimer, University of Calgary
- Investigators
- Raylene A Reimer, PhD, RD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172688
- Sponsor's protocol ID
- REB17-2363
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fortuna R, Wang W, Mayengbam S, Tuplin EWN, Sampsell K, Sharkey KA, Hart DA, Reimer RA. Effect of prebiotic fiber on physical function and gut microbiota in adults, mostly women, with knee osteoarthritis and obesity: a randomized controlled trial. Eur J Nutr. 2024 Sep;63(6):2149-2161. doi: 10.1007/s00394-024-03415-w. Epub 2024 May 7.
PubMed 38713231Fortuna 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.
PubMed 33827639
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotics on Function and Pain in Patients with Knee Osteoarthritis and Obesity
- ClinicalTrials.gov ID
- NCT04172688
- Acronym / sponsor ID
- REB17-2363
- Conditions
- Osteo Arthritis Knee, Obesity
- Keywords
- Pain, Gut microbiota, Prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo maltodextrinTwo 3.3g doses/day (12 kcal/dose) of maltodextrin |
| Prebiotic | Experimental | Dietary Supplement: Prebiotic oligofructose-enriched inulinTwo 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic oligofructose-enriched inulinSynergy1 | Dietary supplement | Prebiotic |
| Placebo maltodextrinEquicaloric dose of maltodextrin | Dietary supplement | Placebo |
Primary outcome
Change in 30 second chair stand test
Time frame: Baseline and 6 months
30 second chair stand test
Change in 40 metre fast based walk
Time frame: Baseline and 6 months
40 metre fast based walk
Change in Time up and go test
Time frame: Baseline and 6 months
Time up and go test
Change in 6 minute walk test
Time frame: Baseline and 6 months
6 minute walk test
Change in knee function
Time frame: Baseline and 6 months
Knee extensor torque isokinetic dynamometer (Biodex System3)
11 secondary outcomes
Change in knee pain
Time frame: Baseline and 6 months
Change in knee injury and osteoarthritis outcome score (KOOS)
Time frame: Baseline and 6 months
Change in pain medication use
Time frame: Baseline and 6 months
Change in body fat
Time frame: Baseline and 6 months
Change in fecal microbiota composition
Time frame: Baseline and 6 months
Change in fecal short chain fatty acids (SCFA) concentration
Time frame: Baseline and 6 months
Change in serum endotoxin
Time frame: Baseline and 6 months
Change in serum inflammatory marker
Time frame: Baseline and 6 months
Change in physical activity level
Time frame: Baseline and 6 months
Change in quality of life ratings
Time frame: Baseline and 6 months
Change in serum metabolomics
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 38713231Fortuna R, Wang W, Mayengbam S, Tuplin EWN, Sampsell K, Sharkey KA, Hart DA, Reimer RA. Effect of prebiotic fiber on physical function and gut microbiota in adults, mostly women, with knee osteoarthritis and obesity: a randomized controlled trial. Eur J Nutr. 2024 Sep;63(6):2149-2161. doi: 10.1007/s00394-024-03415-w. Epub 2024 May 7.
- Derived from this study: PubMed 33827639Fortuna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raylene A Reimer, PhD, RD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic oligofructose-enriched inulin in people with Osteo Arthritis Knee and Obesity, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 30 second chair stand test (time frame: Baseline and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172688, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.