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

Not Applicable

Completed

• Conditions: Low Intensity Knee Gonalgia
• Interventions: Dietary Supplement: Yogurt supplemented with Mobilee; Dietary Supplement: Yogurt

• Registration Number: NCT01303432
• Lead Sponsor: Bioiberica

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobilee yogurt	Yogurt supplemented with Mobilee	Subjects eating daily on yogurt supplemented with Mobilee
Placebo yogurt	Yogurt	Subjects receiving daily a standard yogurt

Primary Outcome Measures

Name	Time	Method
Change from baseline in isokineic assessment of muscular strength	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 Outcome Measures

Name	Time	Method
Change from baseline in isokinetic assessment of muscular strength (other conditions)	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	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)	3 months	Time evolution of pain intensity as measured by Visual Analogue Scale (mm).
SF-36 Health questionnaire	3 months	Questionnaire SF36-v2 to measure physical and mental health.
Number of Participants with Adverse Events	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	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	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

Trial Locations

Locations (1)

Hospital Universitari Sant Joan de Reus; 🇪🇸 Reus, Tarragona, Spain