Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
NCT ID: NCT05279573
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2022-02-14
2022-12-23
Brief Summary
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Detailed Description
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They will make a total of two visits to the research laboratory and will perform the tests pre-established in the protocol. In addition, a follow-up telephone call will be made after 30 days of consume. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Combination of Omega-3 based product and botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Omega-3 and/or botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Omega-3 based product
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Omega-3 and/or botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Omega-3 and/or botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Control group
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Control product consumption
Product with identical characteristics to the experimental product. Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Interventions
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Omega-3 and/or botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Control product consumption
Product with identical characteristics to the experimental product. Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
40 Years
75 Years
ALL
Yes
Sponsors
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Evonik Operations GmbH
UNKNOWN
Universidad Católica San Antonio de Murcia
OTHER
Responsible Party
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Francisco Javier López Román
Principal Investigator
Principal Investigators
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Fco Javier López Roman
Role: PRINCIPAL_INVESTIGATOR
Catholic University of Murcia
Locations
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Catholic University of Murcia
Murcia, , Spain
Countries
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Other Identifiers
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UCAMCFE-00020
Identifier Type: -
Identifier Source: org_study_id