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Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303432
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : September 14, 2012
Sponsor:
Collaborator:
Technological Centre of Nutrition and Health
Information provided by (Responsible Party):
Bioiberica

Tracking Information
First Submitted Date  ICMJE February 21, 2011
First Posted Date  ICMJE February 24, 2011
Last Update Posted Date September 14, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • 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.
  • Safety and tolerability parameters including adverse events, clinical laboratory, and vital signs assessments [ Time Frame: 3 months ]
    The safety assessment includes: Register of adverse events and change from baseline in blood pressure, hearth rate, biochemical profile and body mass index.
  • Subjective evaluation of the intervention [ Time Frame: 3 months ]
    Questionnaire to evaluate the subjective perception of the efficacy of the intervention.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Low Intensity Knee Gonalgia
Intervention  ICMJE
  • Dietary Supplement: Yogurt supplemented with Mobilee
    One yogurt (125mL) per day including 80mg of Mobilee
  • Dietary Supplement: Yogurt
    One yogurt (125mL) per day
Study Arms  ICMJE
  • Experimental: Mobilee yogurt
    Subjects eating daily on yogurt supplemented with Mobilee
    Intervention: Dietary Supplement: Yogurt supplemented with Mobilee
  • Placebo Comparator: Placebo yogurt
    Subjects receiving daily a standard yogurt
    Intervention: Dietary Supplement: Yogurt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2011)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult (between 20 and 70 years of age)
  • Subject with low intensity knee gonalgia (VAS pain intensity between 3 and 5cm during at least the last 6 months)
  • Healthy individual according to its medical records, physical and laboratorial parameters
  • Positive informed consent

Exclusion Criteria:

  • Individuals requiring acetaminophen or any other drug to control pain
  • Active rheumatoid arthritis or any other inflammatory joint disease
  • Oral treatment with corticosteroids 4 weeks before selection
  • Intra-articular treatment with corticosteroids 3 months before selection
  • Significant injury of the study joint 12 months before selection
  • Individuals receiving any drug or supplement for osteoarthritis
  • Individuals requiring any type of medical prescription to control pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303432
Other Study ID Numbers  ICMJE CTNS 001_03_2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bioiberica
Study Sponsor  ICMJE Bioiberica
Collaborators  ICMJE Technological Centre of Nutrition and Health
Investigators  ICMJE
Principal Investigator: Rosa Solà, MD Hospital Universitari Sant Joan de Reus
PRS Account Bioiberica
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP