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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Intensity Knee Gonalgia
- Sponsor
- Bioiberica
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from baseline in isokineic assessment of muscular strength
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change from baseline in isokinetic assessment of muscular strength (other conditions)(3 months)
- Assessment of joint swelling, effusion(3 months)
- Pain assessment (VAS)(3 months)
- SF-36 Health questionnaire(3 months)
- Number of Participants with Adverse Events(3 months)
- Subjective evaluation of the intervention(3 months)
- Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 3 months(3 months)