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.

Study Overview

• Status: Completed
• Conditions: Low Intensity Knee Gonalgia
• Intervention / Treatment: Dietary supplement: Yogurt supplemented with Mobilee; Dietary supplement: Yogurt

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: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43201
      • Hospital Universitari Sant Joan de Reus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in isokineic assessment of muscular strength	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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in isokinetic assessment of muscular strength (other conditions)	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.	3 months
Assessment of joint swelling, effusion	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.	3 months
Pain assessment (VAS)	Time evolution of pain intensity as measured by Visual Analogue Scale (mm).	3 months
SF-36 Health questionnaire	Questionnaire SF36-v2 to measure physical and mental health.	3 months
Number of Participants with Adverse Events	The safety assessment includes a register of the appearance of adverse events along the 3 months of the study	3 months
Subjective evaluation of the intervention	Questionnaire to evaluate the subjective perception of the efficacy of the intervention.	3 months
Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 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	3 months

Collaborators and Investigators

• Sponsor: Bioiberica
• Collaborators: Technological Centre of Nutrition and Health
• Investigators: Principal Investigator: Rosa Solà, MD, Hospital Universitari Sant Joan de Reus

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 21, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): September 14, 2012
• Last Update Submitted That Met QC Criteria: September 13, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Functional Food; Joint discomfort; Joint function; Mobilee
• Other Study ID Numbers: CTNS 001_03_2010