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

Bioiberica80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Low Intensity Knee Gonalgia

Interventions

Yogurt supplemented with MobileeDIETARY_SUPPLEMENT

One yogurt (125mL) per day including 80mg of Mobilee

YogurtDIETARY_SUPPLEMENT

One yogurt (125mL) per day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Outcomes

Primary Outcomes

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).

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 3 months

Pain assessment (VAS)

Time evolution of pain intensity as measured by Visual Analogue Scale (mm).

Time frame: 3 months

SF-36 Health questionnaire

Questionnaire SF36-v2 to measure physical and mental health.

Time frame: 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

Time frame: 3 months

Subjective evaluation of the intervention

Data from ClinicalTrials.gov

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