Clinical trial NCT05279573: Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
Official title: Randomized Controlled Intervention Study to Analyze the Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Function Disorder
Keywords: Omega-3
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
Collaborators: name: Evonik Operations GmbH
First posted: 2022-03-15
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 functionality of the evaluated joint.

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 study groups (A, B, C o D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary regarding pain and concomitant medication.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Pain from baseline at 8 weeks
timeFrame: The evolution of pain after consumption during 8 weeks will be measured.
measure: Quality of life test: WOMAC test
timeFrame: Change in initial quality of life at 8 weeks.
Secondary outcomes:
measure: Change in Pain from baseline at 8 weeks
timeFrame: Pain will be measured with a daily scale, from baseline to 8 weeks.
measure: Functional test
timeFrame: The test will be measured at baseline and after 8 weeks of consumption.
measure: Muscle function
timeFrame: The test will be measured at baseline and after 8 weeks of consumption.
measure: Change in concomitant analgesic medication
timeFrame: The test will be measured at baseline and after 8 weeks of consumption. It will also be evaluated on a daily basis
measure: Sleep efficiency
timeFrame: The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
measure: Sleep quality
timeFrame: It will be measured twice, once at baseline or at the end of the study after 8 weeks of use
measure: Omega-3 Bioavailability
timeFrame: It will be measured twice, once at baseline or at the end of the study after 8 weeks.
measure: Liver safety variables
timeFrame: It will be measured twice, once at baseline or at the end of the study after 8 weeks.
measure: Physical activity
timeFrame: The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
measure: Physical activity control
timeFrame: The test will be measured at baseline and after 8 weeks of consumption.
measure: Body composition
timeFrame: The test will be measured at baseline and after 8 weeks of consumption.
measure: Waist - hip circumference
timeFrame: The test will be measured at baseline and after 8 weeks of consumption.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Fco Javier López Roman
role: PRINCIPAL_INVESTIGATOR
References: