Clinical trial NCT01303432: Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Intensity Knee Gonalgia
Keywords: Joint discomfort
Functional Food
Joint function
Mobilee
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
Collaborators: name: Technological Centre of Nutrition and Health
First posted: 2011-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in isokineic assessment of muscular strength
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in isokinetic assessment of muscular strength (other conditions)
timeFrame: 3 months
measure: Assessment of joint swelling, effusion
timeFrame: 3 months
measure: Pain assessment (VAS)
timeFrame: 3 months
measure: SF-36 Health questionnaire
timeFrame: 3 months
measure: Number of Participants with Adverse Events
timeFrame: 3 months
measure: Subjective evaluation of the intervention
timeFrame: 3 months
measure: Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
Study officials:
affiliation: Hospital Universitari Sant Joan de Reus
name: Rosa Solà, MD
role: PRINCIPAL_INVESTIGATOR
References: