Completed

NCT Number: NCT01303432

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

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.

Completed

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Key information

Conditions

Low Intensity Knee Gonalgia

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43201, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogurt supplemented with Mobilee

Dietary Supplement

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

Yogurt

Dietary Supplement

One yogurt (125mL) per day

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)

Time frame: 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

Time frame: 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)

Time frame: 3 months

Time evolution of pain intensity as measured by Visual Analogue Scale (mm).
SF-36 Health questionnaire

Time frame: 3 months

Questionnaire SF36-v2 to measure physical and mental health.
Number of Participants with Adverse Events

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Bioiberica

Industry

Collaborators

Technological Centre of Nutrition and Health

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Feb 24, 2011
Registry last updated: Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.