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
  Purpose

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.


Condition Intervention
Low Intensity Knee Gonalgia
Dietary Supplement: Yogurt supplemented with Mobilee
Dietary Supplement: Yogurt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Bioiberica:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 80
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303432

Locations
Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain, 43201
Sponsors and Collaborators
Bioiberica
Technological Centre of Nutrition and Health
Investigators
Principal Investigator: Rosa Solà, MD Hospital Universitari Sant Joan de Reus
  More Information

Additional Information:
No publications provided

Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT01303432     History of Changes
Other Study ID Numbers: CTNS 001_03_2010
Study First Received: February 21, 2011
Last Updated: September 13, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Bioiberica:
Joint discomfort
Functional Food
Joint function
Mobilee

ClinicalTrials.gov processed this record on October 19, 2014