Joint Function Disorder
Conditions
Keywords
Omega-3
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 and/or botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
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.
Sponsors
Evonik Operations GmbH
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain from baseline at 8 weeks | The evolution of pain after consumption during 8 weeks will be measured. | Visual analog scale from 0 to 10. The higher the value, the more pain. |
| Quality of life test: WOMAC test | Change in initial quality of life at 8 weeks. | The quality of life of the subjects will be measured with the WOMAC test. It is a 24-item test that will measure the degree of pain: nothing, little, enough and a lot, when performing activities in daily life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle function | The test will be measured at baseline and after 8 weeks of consumption. | Isokinetic and isometric dynamometry |
| Change in concomitant analgesic medication | The test will be measured at baseline and after 8 weeks of consumption. It will also be evaluated on a daily basis | The change in the need for the use of analgesic medications will be evaluated |
| Sleep efficiency | The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day. | Measured by accelerometry, with Actigraph wGT3X-BT |
| Sleep quality | It will be measured twice, once at baseline or at the end of the study after 8 weeks of use | Measured by Pittsburgh test |
| Omega-3 Bioavailability | It will be measured twice, once at baseline or at the end of the study after 8 weeks. | Measured by omega quant |
| Change in Pain from baseline at 8 weeks | Pain will be measured with a daily scale, from baseline to 8 weeks. | Visual analog scale from 0 to 10. The higher the value, the more pain. |
| Physical activity | The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day. | It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT |
| Physical activity control | The test will be measured at baseline and after 8 weeks of consumption. | It is a control variable. Measured by fitbit |
| Body composition | The test will be measured at baseline and after 8 weeks of consumption. | It is a control variable. Measured by bioimpedance |
| Waist - hip circumference | The test will be measured at baseline and after 8 weeks of consumption. | It is a control variable. |
| Liver safety variables | It will be measured twice, once at baseline or at the end of the study after 8 weeks. | It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L) |
| Functional test | The test will be measured at baseline and after 8 weeks of consumption. | The balance and mobility of the subjects will be measured with the Timed Up and Go Test |
Countries
Spain
Outcome results
None listed