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| Name | Class |
|---|---|
| Technological Centre of Nutrition and Health | OTHER |
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The purpose of this study is to determine whether the daily eating of a yogurt supplemented with Mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia.
The prevalence of low intensity gonalgia is relatively high in western population. The purpose of the present intervention study is to determine whether the daily consumption of a yogurt supplemented with Mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia. Previous research using in vitro and animal models have demonstrated the efficacy of Mobilee in reducing inflammation and promoting anabolic responses in joint tissues. In addition, in two previous human intervention trials, the effects of Mobilee in joint function had been assessed using isokinetic tests. The present trial aims to confirm those previous results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobilee yogurt | Experimental | Subjects eating daily on yogurt supplemented with Mobilee |
|
| Placebo yogurt | Placebo Comparator | Subjects receiving daily a standard yogurt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yogurt supplemented with Mobilee | Dietary Supplement | One yogurt (125mL) per day including 80mg of Mobilee |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in isokineic assessment of muscular strength | The muscular isokinetic assessment determines peak torque, power mean and total work of a certain joint using a dynamometric computerized system. The principal parameter is the change from baseline in the peak torque of the affected joint in extension at a speed of 240º/sec measured in Nm (Newton-meter). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in isokinetic assessment of muscular strength (other conditions) | Change from baseline of peak torque (Nm), power mean (W) and total work (J) of the affected joint in extension at 180º/sec, and in flexion at 240º/sec and 180º/sec. | 3 months |
| Assessment of joint swelling, effusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Solà , MD | Hospital Universitari Sant Joan de Reus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Sant Joan de Reus | Reus | Tarragona | 43201 | Spain |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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| ID | Term |
|---|---|
| D015014 | Yogurt |
| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
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| Yogurt | Dietary Supplement | One yogurt (125mL) per day |
|
Ultrasonography: Study of the synovial effusion degree (if any) measured in the longitudinal axis of the suprapatellar recess of the affected knee.Results are expressed as change from baseline in mm. |
| 3 months |
| Pain assessment (VAS) | Time evolution of pain intensity as measured by Visual Analogue Scale (mm). | 3 months |
| SF-36 Health questionnaire | Questionnaire SF36-v2 to measure physical and mental health. | 3 months |
| Number of Participants with Adverse Events | The safety assessment includes a register of the appearance of adverse events along the 3 months of the study | 3 months |
| Subjective evaluation of the intervention | Questionnaire to evaluate the subjective perception of the efficacy of the intervention. | 3 months |
| Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 3 months | Safety assessment includes an evaluation at 3 months of changes from baseline on systolic blood pressure, hearth rate, general biochemical profile and body mass index | 3 months |
| D010829 |
| Physiological Phenomena |
| D000074421 | Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |