Joint DiscomfortNCT02843620
Efficacy and Safety of b-2Cool on Adults With Joint Discomfort
A study testing b-2Cool in people with Joint Discomfort, run by Bioiberica.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Joint Discomfort
- What is being tested?
- b-2Cool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 2018
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) .
Who cannot join
- 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 .
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Joint Discomfort
- Being tested
- b-2Cool, Placebo
- Keywords
- Native Collagen, Joint, Joint Discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
b-2CoolDietary supplement
b-2Cool® is native type II collagen extracted from chicken sternums
PlaceboOther
Excipients only
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo arm will take a pill each day containing only excipients Receives: Other: Placebo |
| b-2Cool | Experimental | The b-2Cool arm will take a pill each day containing 40 mg of b-2Cool and excipients Receives: Dietary Supplement: b-2Cool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of ultrasonographic assessment of synovial effusion
Measured: 0, 6, 12 and 24 weeks
Secondary outcomes (7)
Visual Analog Scale (VAS) pain evaluation
Measured: 0, 6, 12 and 24 weeks
WOMAC Functional assesment
Measured: 0, 6, 12 and 24 weeks
Subjective evaluation of quality of life
Patients will report some aspects of their Quality of life through Visual analogic scales
Measured: 0, 6, 12 and 24 weeks
Collagen degradation markers in urine
Measured: 0, 12 and 24 weeks
Patient's satisfaction
Patient satisfaction will be evaluated using a subjective questionnaire
Measured: 6, 12 and 24 weeks
Rescue medication consumption
Measured: Every 2 weeks for 24 weeks
Adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Enrollment not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiscomfortStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingrid Möller, Dr., Principal investigator, Instituto Poal de Reumatología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843620
- Sponsor's protocol ID
- PRJ290
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2016
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02843620
- Acronym / sponsor ID
- PRJ290
- Conditions
- Joint Discomfort
- Keywords
- Native Collagen, Joint, Joint Discomfort
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboThe placebo arm will take a pill each day containing only excipients |
| b-2Cool | Experimental | Dietary Supplement: b-2CoolThe b-2Cool arm will take a pill each day containing 40 mg of b-2Cool and excipients |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| b-2Coolb-2Cool® is native type II collagen extracted from chicken sternums | Dietary supplement | b-2Cool |
| PlaceboExcipients only | Other | Placebo |
Primary outcome
Change from baseline of ultrasonographic assessment of synovial effusion
Time frame: 0, 6, 12 and 24 weeks
7 secondary outcomes
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
Collagen degradation markers in urine
Time frame: 0, 12 and 24 weeks
Patient's satisfaction
Time frame: 6, 12 and 24 weeks
Rescue medication consumption
Time frame: Every 2 weeks for 24 weeks
Adverse events
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Ingrid Möller, Dr. principal investigator
Instituto Poal de Reumatología
Questions about this trial
What is this clinical trial studying?
A study testing b-2Cool in people with Joint Discomfort, run by Bioiberica.
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 7 inclusion and 15 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: withdrawn, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 from baseline of ultrasonographic assessment of synovial effusion (time frame: 0, 6, 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2018.