Status:
COMPLETED
Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Collaborating Sponsors:
Evonik Operations GmbH
Conditions:
Joint Function Disorder
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
Randomized, controlled, double-blind intervention study of four parallel branches depending on the product consumed, to analyze the efficacy of an Omega-3 based product on the mobility and functionali...
Detailed Description
The duration of the study will be 60 days (8 weeks). Each day they will have to consume the product under investigation. Subjects who meet the selection criteria will be randomized into each of the st...
Eligibility Criteria
Inclusion
- Healthy adults (age: 40-75 YO).
- Subjects must have persistent knee pain with a baseline VAS pain assessment score of at least 30 mm.
- Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.
Exclusion
- Serious or terminal illnesses.
- Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
- Subjects who are currently consuming or have consumed in the last two months any Omega-3 based supplement and/or supplement based on the botanical ingredient under investigation.
- Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
- Subjects with a body mass index above 32.
- Subjects with known allergy to any of the study components.
- Pregnant or lactating women.
- Inability to understand informed consent.
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05279573
Start Date
February 14 2022
End Date
December 23 2022
Last Update
December 28 2022
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107