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

NCT ID: NCT01303432

Last Updated: 2012-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Low Intensity Knee Gonalgia

Keywords

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Joint discomfort Functional Food Joint function Mobilee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mobilee yogurt

Subjects eating daily on yogurt supplemented with Mobilee

Group Type EXPERIMENTAL

Yogurt supplemented with Mobilee

Intervention Type DIETARY_SUPPLEMENT

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

Placebo yogurt

Subjects receiving daily a standard yogurt

Group Type PLACEBO_COMPARATOR

Yogurt

Intervention Type DIETARY_SUPPLEMENT

One yogurt (125mL) per day

Interventions

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Yogurt supplemented with Mobilee

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

Intervention Type DIETARY_SUPPLEMENT

Yogurt

One yogurt (125mL) per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technological Centre of Nutrition and Health

OTHER

Sponsor Role collaborator

Bioiberica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosa Solà, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Sant Joan de Reus

Locations

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Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Site Status

Countries

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Spain

Related Links

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http://www.cdti.es/

Related Info

Other Identifiers

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CTNS 001_03_2010

Identifier Type: -

Identifier Source: org_study_id