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

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.

Study Overview

• Status: Withdrawn
• Conditions: Joint Discomfort
• Intervention / Treatment: Other: Placebo; Dietary supplement: b-2Cool

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: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of ultrasonographic assessment of synovial effusion	0, 6, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		6 months
Visual Analog Scale (VAS) pain evaluation		0, 6, 12 and 24 weeks
WOMAC Functional assesment		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	0, 6, 12 and 24 weeks
Collagen degradation markers in urine		0, 12 and 24 weeks
Patient's satisfaction	Patient satisfaction will be evaluated using a subjective questionnaire	6, 12 and 24 weeks
Rescue medication consumption		Every 2 weeks for 24 weeks

Collaborators and Investigators

• Sponsor: Bioiberica
• Investigators: Principal Investigator: Ingrid Möller, Dr., Instituto Poal de Reumatología

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Joint; Native Collagen; Joint Discomfort
• Other Study ID Numbers: PRJ290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No