Status:
COMPLETED
Effects of Chicken Extract and Collagen on Mobility
Lead Sponsor:
Shan May Yong
Collaborating Sponsors:
Chang Gung Memorial Hospital
Conditions:
Knee Osteoarthritis
Muscle Loss
Eligibility:
All Genders
45-75 years
Phase:
PHASE1
Brief Summary
A randomized, double-blind placebo-controlled trial to study the effects of chicken extract and collagen on join, bone and muscle functions in comparison to an active comparator glucosamine
Detailed Description
Osteoarthritis (OA) of the knee, which entails the destruction of knee cartilage and remodeling of the adjacent bone, is one of the leading causes of disability among elderly adults. Consequences of s...
Eligibility Criteria
Inclusion
- Male/female at 45 - 75 years of age
- Subject has a body mass index range of 18.0 to 30.0 kg/m2, inclusive, and weighs at least 40 kg at screening
- Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the study.
- Experience knee pain ≥ 3 months
- WOMAC total pain score ≥ 6 evaluated by walking on a flat surface, descending and/or ascending stairs
- Subject has mild-to-moderate knee osteoarthritis (OA) at grade 1 - 3 per Kellgren-Lawrence grading system
- Experience loss in muscular strength or physical performance greater than 1 year
- Be willing to refrain from hormone therapy and dietary supplements such as calcium, vitamin D, supplements enriched with proteins, omega-3, omega-6, glucosamine, or chondroitin during the entire study
Exclusion
- Inability to participate in the evaluation of the study
- Active viral infection or bacterial infection based on clinical observations
- Subjects with history of rheumatoid arthritis or any other inflammatory arthritis
- Chronic medical conditions including renal dysfunctions, psychiatric disorders, or diabetes (or HbA1c \> 6.5%)
- History of stroke or myocardial infarction, mental retardation, or schizophrenia
- Gout
- Paget disease of bone or spinal disc herniation
- Subjects intolerant or allergic to protein-based food or supplement
- Anti-osteoporotic therapy in the past year
- Intra-articular injection during previous 3 months (6 months for hyaluronic acid) applied at target knee joint (most painful knee joint at Screening visit)
- Current corticosteroid therapy
- Those expecting knee arthroscopy or arthroplasty
- Life-threatening pathology (such as cancer) in remission for less than 1 year or still ongoing
- Psychological or linguistic incapability to sign the informed consent
- History of allergy to chicken meat
- Pregnant or lactating women
- Suspected or known alcohol abuse or addiction (consume ≥ 14 drinks of alcohol per week; 1 drink: \~355-mL beer or 150-mL wine)
- Subjects with any other conditions or diseases that investigator considers not appropriate to be entered in the study
- Subjects with active pathology that could confound interpretation of knee pain or any conditions that interfere with adherence
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04483024
Start Date
December 1 2018
End Date
December 1 2019
Last Update
July 29 2020
Active Locations (1)
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1
Linkou Chang Gung Memorial Hospital
Taipei, Taiwan