Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort
|ClinicalTrials.gov Identifier: NCT01303432|
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : September 14, 2012
|Condition or disease||Intervention/treatment|
|Low Intensity Knee Gonalgia||Dietary Supplement: Yogurt supplemented with Mobilee Dietary Supplement: Yogurt|
|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|
|Primary Completion Date :||March 2011|
|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
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|