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

Bioiberica

Status

Withdrawn

Conditions

Joint Discomfort

Treatments

Other: Placebo

Dietary Supplement: b-2Cool

Study type

Interventional

Funder types

Industry

Identifiers

NCT02843620

PRJ290

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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