Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort
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|ClinicalTrials.gov Identifier: NCT01303432|
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : September 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Low Intensity Knee Gonalgia||Dietary Supplement: Yogurt supplemented with Mobilee Dietary Supplement: Yogurt||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Double-blind, Placebo-controlled Nutrition Intervention Trial, to Study Efficacy and Safety of Yogurts Supplemented With Mobilee on Joint Function, Joint Structure and Quality of Life of Adults With Low Intensity Gonalgia|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Mobilee yogurt
Subjects eating daily on yogurt supplemented with Mobilee
Dietary Supplement: Yogurt supplemented with Mobilee
One yogurt (125mL) per day including 80mg of Mobilee
Placebo Comparator: Placebo yogurt
Subjects receiving daily a standard yogurt
Dietary Supplement: Yogurt
One yogurt (125mL) per day
- Change from baseline in isokineic assessment of muscular strength [ Time Frame: 3 months ]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).
- Change from baseline in isokinetic assessment of muscular strength (other conditions) [ Time Frame: 3 months ]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.
- Assessment of joint swelling, effusion [ Time Frame: 3 months ]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.
- Pain assessment (VAS) [ Time Frame: 3 months ]Time evolution of pain intensity as measured by Visual Analogue Scale (mm).
- SF-36 Health questionnaire [ Time Frame: 3 months ]Questionnaire SF36-v2 to measure physical and mental health.
- Number of Participants with Adverse Events [ Time Frame: 3 months ]The safety assessment includes a register of the appearance of adverse events along the 3 months of the study
- Subjective evaluation of the intervention [ Time Frame: 3 months ]Questionnaire to evaluate the subjective perception of the efficacy of the intervention.
- Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 3 months [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303432
|Hospital Universitari Sant Joan de Reus|
|Reus, Tarragona, Spain, 43201|
|Principal Investigator:||Rosa Solà, MD||Hospital Universitari Sant Joan de Reus|