It is hypothesized that chicken eggshell membrane is effective in the regeneration of cartilage and/or immunomodulation (oral tolerance), and as such positively affects pain and stiffness in joints commonly affected in arthritis
ID
Bron
Aandoening
osteoarthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Main study endpoint includes assessment of self-reported pain (0-10) on a Numerical Rating Scale (NRS pain) after 6 weeks
Achtergrond van het onderzoek
Poor joint health is a significant burden to society. Millions of people suffer from a kind of joint related disorder or disease, most often osteoarthritis. In those cases the cartilage in the joint is affected through inflammation, and/or inadequate balance of cartilage build-up versus degradation. It is hypothesized that chicken eggshell membrane is effective in the regeneration of cartilage and/or immunomodulation (oral tolerance), and as such positively affects pain and stiffness in joints commonly affected in arthritis. The main objective is to demonstrate a significant improvement in self-reported pain after 6 weeks of consumption of eggshell membrane in a typical population. Secondary, stiffness and performance indices will be assessed. The study will be set-up as a randomized, double-blind, placebo controlled intervention trial. One-hundred and fifty (150) volunteers, men and women, 40-75 years old diagnosed who meet all of the inclusion criteria and none of the exclusion criteria will be included in the study. For a period of 12 weeks one group receives a daily capsule containing eggshell membrane, and the other group daily receives a placebo capsule.
Doel van het onderzoek
It is hypothesized that chicken eggshell membrane is effective in the regeneration of cartilage and/or immunomodulation (oral tolerance), and as such positively affects pain and stiffness in joints commonly affected in arthritis
Onderzoeksopzet
0,3,6,12 weeks
Onderzoeksproduct en/of interventie
For a period of 12 weeks one group receives a daily capsule containing eggshell membrane, and the other group daily receives a placebo capsule.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Age between 40-75
• NRS pain of 3 or more
• Diagnosed with osteoarthritis of the knee (confirmed by Health Care Professional)
• Able to understand, read, and write Dutch
• Daily access to e-mail and internet
• Non-smoking
• Signed informed consent
• Willing to comply with study procedures
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• NRS pain of 9 or 10
• Use of supplements aimed to target specifically osteoarthritis and/or rheumatoid arthritis (including glucosamine, chondroitin, collagen, MSM, green lip mussel, Boswelia extract or the-like) within 2 months prior to the start of the study
• Known allergy to eggs or egg products
• Pregnant or breastfeeding women
• Previously enrolment in a study to evaluate pain relief within the past 6 months or currently involved in any other research study involving an investigational product (drug, device, or biologic) or a new application of an approved product
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7309 |
| NTR-old | NTR7525 |
| Ander register | METC (IRBN, Nijmegen) : ABR 64636 |