NCT04172688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2.9 years

First QC Date

November 13, 2019

Last Update Submit

December 3, 2024

Conditions

Osteo Arthritis KneeObesity

Keywords

PainGut microbiotaPrebiotic

Outcome Measures

Primary Outcomes (5)

  • Change in 30 second chair stand test

    30 second chair stand test

    Baseline and 6 months

  • Change in 40 metre fast based walk

    40 metre fast based walk

    Baseline and 6 months

  • Change in Time up and go test

    Time up and go test

    Baseline and 6 months

  • Change in 6 minute walk test

    6 minute walk test

    Baseline and 6 months

  • Change in knee function

    Knee extensor torque isokinetic dynamometer (Biodex System3)

    Baseline and 6 months

Secondary Outcomes (11)

  • Change in knee pain

    Baseline and 6 months

  • Change in knee injury and osteoarthritis outcome score (KOOS)

    Baseline and 6 months

  • Change in pain medication use

    Baseline and 6 months

  • Change in body fat

    Baseline and 6 months

  • Change in fecal microbiota composition

    Baseline and 6 months

  • +6 more secondary outcomes

Other Outcomes (1)

  • Change in gastrointestinal comfort

    Baseline and 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Two 3.3g doses/day (12 kcal/dose) of maltodextrin

Dietary Supplement: Placebo maltodextrin

Prebiotic

EXPERIMENTAL

Two 8g doses/day (12 kcal/dose) of oligofructose-enriched inulin

Dietary Supplement: Prebiotic oligofructose-enriched inulin

Interventions

Prebiotic oligofructose-enriched inulinDIETARY_SUPPLEMENT

Synergy1

Prebiotic
Placebo maltodextrinDIETARY_SUPPLEMENT

Equicaloric dose of maltodextrin

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 38713231DERIVED

  • 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.

    PMID: 33827639DERIVED

MeSH Terms

Conditions

ObesityPain

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Officials

  • Raylene A Reimer, PhD, RD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 21, 2019

Study Start

November 18, 2018

Primary Completion

October 1, 2021

Study Completion

October 30, 2022

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)