NCT03072108

Brief Summary

This clinical study evaluates if the oral administration of Bonolive can contribute to the improvement of functionnality in healthy elderly people with knee discomfort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration 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

June 24, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

January 31, 2017

Last Update Submit

October 8, 2018

Conditions

Knee DiscomfortKnee Pain

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the effect of investigational product after 6 months of supplementation

    KOOS (Knee injury and Osteoarthritis Outcome Score)

    From Baseline to 6 months of product administration and compared to Placebo

  • Evaluation of the effect of investigational product after 6 months of supplementation

    Biomarker of cartilage breakdown (Coll2.1-NO2)

    From Baseline to 6 months of product administration and compared to Placebo

Secondary Outcomes (2)

  • Evaluation of the effect of investigational product

    From Baseline to 6 months of product administration and compared to Placebo

  • Evaluation of the effect of investigational product

    From Baseline to 6 months of product administration and compared to Placebo

Other Outcomes (1)

  • Evaluation of food habits and frequency using patient-reported questionnaire

    From the date of inclusion until end of study, on a monthly basis, up to 6 months

Study Arms (2)

Bonolive

EXPERIMENTAL
Dietary Supplement: Bonolive

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

BonoliveDIETARY_SUPPLEMENT

2 caps per day of Bonolive

Bonolive
PlaceboDIETARY_SUPPLEMENT

2 caps per day of Placebo

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 55 years of age
  • BMI between 18.5 and 29.9 kg/m2 (normo and overweight)
  • Moderate knee pain (the most painful knee is considered)
  • Able to follow the instructions of the study
  • Able to perform physical tests
  • Having signed an informed consent

You may not qualify if:

  • Related to knee
  • Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee
  • Subject with knee/joint surgery/replacement and ACL (Cross Ligament) injury in the target knee
  • Concurrent articular disease interfering with the evaluation of pain such as articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis
  • Prosthesis in the target knee
  • Diagnosed arthrosis eligible to knee/joint surgery/replacement
  • Related to treatments
  • Hyaluronan injection in the target knee in the last 6 months
  • Oral corticotherapy ≥ 5mg/day in the last 3 months
  • Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
  • Other dietary supplements used for articular disorders in the last 3 months
  • An anticipated need for the duration of the trial of corticosteroids or hyaluronan injection, oral corticotherapy, arthroscopy, analgesics other than listed as rescue treatments, which are forbidden during the trial
  • Arthroscopy in the last 6 months
  • Allergy or contra-indication to Oleuropein, to maltodextrin or any ingredient present in the product, or intolerance to rescue treatment (Paracetamol and NSAIDs)
  • Related to associated diseases
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

MeSH Terms

Interventions

Bonolive

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

March 7, 2017

Study Start

June 24, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)