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Krill and Greenshell Mussel (GSM) on joint health and osteoarthritis

Phase 3
Conditions
Joint Health
Osteoarthritis
Musculoskeletal - Normal musculoskeletal and cartilage development and function
Musculoskeletal - Osteoarthritis
Registration Number
ACTRN12620001154998
Lead Sponsor
RDC Global Pty Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
80
Inclusion Criteria

•Males and females aged over 45 years old inclusive
•Diagnosed with osteoarthritis
•Reporting joint pain (not associated with acute injury, long-standing disease or prescription medication use)
•Otherwise healthy, BMI 18.5-34.9 kg/m2
•Able to provide informed consent
•Agree not to change current diet and exercise program
•Access to internet

Exclusion Criteria

•Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland function malignancy)*
•Malignancy (current) or treatment (chemotherapy and radiotherapy) for malignancy within the previous 2 years
•Clinically significant acute or chronic inflammation, or connective tissue disease including, but not limited to rheumatoid arthritis, bursitis or gout.
•Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
•Receiving treatment or taking supplements for joint pain/health such as glucosamine and omega-3 containing products#.
•Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
•Chronic past and/or current alcohol use (>14 alcoholic drinks week)
•Allergic to seafood or any of the ingredients in the active or placebo formula
•Known pregnant or lactating woman
•Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
•Participants who have participated in any other related clinical study during the past 1 month
•History of infection in the month prior to the study

*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

#Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Joint pain as measured by Visual Analog Scale[Baseline, Week 2, 4, 6 and 8 ]
Secondary Outcome Measures
NameTimeMethod
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