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

This study has been completed.
Sponsor:
Collaborator:
Technological Centre of Nutrition and Health
Information provided by (Responsible Party):
Bioiberica
ClinicalTrials.gov Identifier:
NCT01303432
First received: February 21, 2011
Last updated: September 13, 2012
Last verified: September 2012

February 21, 2011
September 13, 2012
September 2010
March 2011   (final data collection date for primary outcome measure)
Change from baseline in isokineic assessment of muscular strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01303432 on ClinicalTrials.gov Archive Site
  • Change from baseline in isokinetic assessment of muscular strength (other conditions) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time evolution of pain intensity as measured by Visual Analogue Scale (mm).
  • SF-36 Health questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Questionnaire SF36-v2 to measure physical and mental health.
  • Number of Participants with Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
  • Change from baseline in isokinetic assessment of muscular strength (other conditions) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time evolution of pain intensity as measured by Visual Analogue Scale (mm).
  • SF-36 Health questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Questionnaire to evaluate the subjective perception of the efficacy of the intervention.
Not Provided
Not Provided
 
Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Low Intensity Knee Gonalgia
  • Dietary Supplement: Yogurt supplemented with Mobilee
    One yogurt (125mL) per day including 80mg of Mobilee
  • Dietary Supplement: Yogurt
    One yogurt (125mL) per day
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01303432
CTNS 001_03_2010
No
Bioiberica
Bioiberica
Technological Centre of Nutrition and Health
Principal Investigator: Rosa Solà, MD Hospital Universitari Sant Joan de Reus
Bioiberica
September 2012

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