Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Intervention Study to Analyze the Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function

Conditions
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Joint Function Disorder

Intervention / Treatment
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* Dietary Supplement: Omega-3 and/or botanical ingredient
* Other: Control product consumption


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of Omega-3 based product and botanical ingredient<br>Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. | Dietary Supplement: Omega-3 and/or botanical ingredient<br>* Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.<br>|
| Experimental: Omega-3 based product<br>Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. | Dietary Supplement: Omega-3 and/or botanical ingredient<br>* Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.<br>|
| Experimental: Botanical ingredient<br>Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. | Dietary Supplement: Omega-3 and/or botanical ingredient<br>* Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.<br>|
| Placebo Comparator: Control group<br>Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon. | Other: Control product consumption<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3