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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Recruitment Status : Withdrawn (Enrollment not started)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

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.

Condition or disease Intervention/treatment Phase
Joint Discomfort Dietary Supplement: b-2Cool Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
The placebo arm will take a pill each day containing only excipients
Other: Placebo
Excipients only

Experimental: b-2Cool
The b-2Cool arm will take a pill each day containing 40 mg of b-2Cool and excipients
Dietary Supplement: b-2Cool
b-2Cool® is native type II collagen extracted from chicken sternums




Primary Outcome Measures :
  1. Change from baseline of ultrasonographic assessment of synovial effusion [ Time Frame: 0, 6, 12 and 24 weeks ]

Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) pain evaluation [ Time Frame: 0, 6, 12 and 24 weeks ]
  2. WOMAC Functional assesment [ Time Frame: 0, 6, 12 and 24 weeks ]
  3. 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

  4. Collagen degradation markers in urine [ Time Frame: 0, 12 and 24 weeks ]
  5. Patient's satisfaction [ Time Frame: 6, 12 and 24 weeks ]
    Patient satisfaction will be evaluated using a subjective questionnaire

  6. Rescue medication consumption [ Time Frame: Every 2 weeks for 24 weeks ]
  7. Adverse events [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843620


Sponsors and Collaborators
Bioiberica
Investigators
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Principal Investigator: Ingrid Möller, Dr. Instituto Poal de Reumatología
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Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT02843620    
Other Study ID Numbers: PRJ290
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bioiberica:
Native Collagen
Joint
Joint Discomfort