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| Name | Class |
|---|---|
| Evonik Operations GmbH | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of Omega-3 based product and botanical ingredient | Experimental | Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
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| Omega-3 based product | Experimental | Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
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| Botanical ingredient | Experimental | Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
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| Control group | Placebo Comparator | Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 and/or botanical ingredient | Dietary Supplement | Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain from baseline at 8 weeks | Visual analog scale from 0 to 10. The higher the value, the more pain. | The evolution of pain after consumption during 8 weeks will be measured. |
| Quality of life test: WOMAC test | 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. | Change in initial quality of life at 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain from baseline at 8 weeks | Visual analog scale from 0 to 10. The higher the value, the more pain. | Pain will be measured with a daily scale, from baseline to 8 weeks. |
| Functional test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fco Javier López Roman | Catholic University of Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
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| Control product consumption | Other | 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. |
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The balance and mobility of the subjects will be measured with the Timed Up and Go Test
| The test will be measured at baseline and after 8 weeks of consumption. |
| Muscle function | Isokinetic and isometric dynamometry | The test will be measured at baseline and after 8 weeks of consumption. |
| Change in concomitant analgesic medication | The change in the need for the use of analgesic medications will be evaluated | The test will be measured at baseline and after 8 weeks of consumption. It will also be evaluated on a daily basis |
| Sleep efficiency | Measured by accelerometry, with Actigraph wGT3X-BT | The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day. |
| Sleep quality | Measured by Pittsburgh test | It will be measured twice, once at baseline or at the end of the study after 8 weeks of use |
| Omega-3 Bioavailability | Measured by omega quant | It will be measured twice, once at baseline or at the end of the study after 8 weeks. |
| Liver safety variables | 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) | It will be measured twice, once at baseline or at the end of the study after 8 weeks. |
| Physical activity | It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT | The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day. |
| Physical activity control | It is a control variable. Measured by fitbit | The test will be measured at baseline and after 8 weeks of consumption. |
| Body composition | It is a control variable. Measured by bioimpedance | The test will be measured at baseline and after 8 weeks of consumption. |
| Waist - hip circumference | It is a control variable. | The test will be measured at baseline and after 8 weeks of consumption. |