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Efficacy and Safety of b-2Cool on Adults With Joint Discomfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843620
Recruitment Status : Withdrawn (Enrollment not started)
First Posted : July 26, 2016
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bioiberica

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date July 20, 2018
Estimated Study Start Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
Change from baseline of ultrasonographic assessment of synovial effusion [ Time Frame: 0, 6, 12 and 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
  • Visual Analog Scale (VAS) pain evaluation [ Time Frame: 0, 6, 12 and 24 weeks ]
  • WOMAC Functional assesment [ Time Frame: 0, 6, 12 and 24 weeks ]
  • Subjective evaluation of quality of life [ Time Frame: 0, 6, 12 and 24 weeks ]
    Patients will report some aspects of their Quality of life through Visual analogic scales
  • Collagen degradation markers in urine [ Time Frame: 0, 12 and 24 weeks ]
  • Patient's satisfaction [ Time Frame: 6, 12 and 24 weeks ]
    Patient satisfaction will be evaluated using a subjective questionnaire
  • Rescue medication consumption [ Time Frame: Every 2 weeks for 24 weeks ]
  • Adverse events [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of b-2Cool on Adults With Joint Discomfort
Official Title  ICMJE Randomized Double-blind, Placebo Controlled Study to Asses the Efficacy and Safety of a Native Collagen Food Supplement on Joint Function, Ultrasound Evolution and Quality of Life of Adults With Moderate Knee Pain
Brief Summary This study evaluates the effects of 40 mg of b-2Cool, a food supplement rich in native type-II collagen, on healthy adults with joint discomfort. Half of the participants will receive the b-2Cool containing supplement while the other half will receive a placebo pill.
Detailed Description

Previous studies had shown the efficacy of the intake of native collagen to relieve pain in healthy patients with joint discomfort.

Native collagen is detected in the gut's Peyer's patches and, thanks to a mechanism known as oral tolerisation, reduces the autoimmune attack to joints' collagen improving joint function and pain.

Oral tolerance consists of two phases of immune response: the maintenance of homeostasis and the suppression of immune responses mediated by Ag-specific regulatory T cells. T-cells detect the epitopes of type-II collagen in the gut and suppress the immune response against bodily type-II collagen. Then, these regulatory T cells generated in the gut are presumed to migrate to a local microenvironment where a protein analogous to the orally dosed antigen resides, in this case type-II collagen. Upon reactivation in a new microenvironment, regulatory cells will suppress ongoing inflammation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Joint Discomfort
Intervention  ICMJE
  • Dietary Supplement: b-2Cool
    b-2Cool® is native type II collagen extracted from chicken sternums
  • Other: Placebo
    Excipients only
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    The placebo arm will take a pill each day containing only excipients
    Intervention: Other: Placebo
  • Experimental: b-2Cool
    The b-2Cool arm will take a pill each day containing 40 mg of b-2Cool and excipients
    Intervention: Dietary Supplement: b-2Cool
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 19, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2016)
60
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults between 40 and 75 years old.
  • Subject who suffers mild joint discomfort (value between 3 and 5 VAS scale for a minimum of 6 months).
  • Subject that after reading and understanding the study's protocol has provided written informed consent to participate in the study.
  • Subjects willing to keep stable eating and activity patterns during the duration of the study.
  • Subjects who use other therapies for joint discomfort, such as exercise, heat / cold, joint protection and physiotherapy / occupational therapy agree to follow the treatments avoiding changes in the frequency or intensity of them and reporting them at baseline and during follow-ups.
  • Subjects agree not start any new therapy during the study period.
  • Subjects who have lateral or longitudinal knee synovial effusion according to the index OMERACT (Outcome Measures in Rheumatology) .

Exclusion Criteria:

  • Active rheumatoid arthritis, diagnosed osteoarthritis or any other inflammatory arthritic condition that researchers consider non appropriate.
  • Being pregnant or lactating.
  • Be waiting for joint surgery or major surgery in the next 8 months
  • Joint injury in the last 4 months in the area osteoarthritis-affected (i.e. meniscal tear)
  • Having underwent reconstructive surgery on the cartilage of the affected knee
  • Background of peptidic ulcer and other symptomatic/active disorders of the intestinal tract that may interfere with product under evaluation .
  • History of congestive heart failure,
  • Allergy to chicken or other ingredients in the product
  • Anticipated problems with product consumption
  • High alcohol consumption (> 2 drinks per day)
  • History of psychiatric disorders that may impede the ability of subjects to give written informed consent
  • Failure to comply with washout periods before the start of the study.
  • Paracetamol intake 24 hours before randomization
  • The subject does not want to stop taking medication in addition to the study medication (for arthritis or other pain) or not to take other types of medication for the treatment of osteoarthritis pain
  • Other conditions that, in the opinion of the principal investigator adversely affect the subject's ability to complete the study or its measures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843620
Other Study ID Numbers  ICMJE PRJ290
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bioiberica
Study Sponsor  ICMJE Bioiberica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ingrid Möller, Dr. Instituto Poal de Reumatología
PRS Account Bioiberica
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP