NCT01303432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

6 months

First QC Date

February 21, 2011

Last Update Submit

September 13, 2012

Conditions

Low Intensity Knee Gonalgia

Keywords

Joint discomfortFunctional FoodJoint functionMobilee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change from baseline in isokinetic assessment of muscular strength (other conditions)

    3 months

  • Assessment of joint swelling, effusion

    3 months

  • Pain assessment (VAS)

    3 months

  • SF-36 Health questionnaire

    3 months

  • Number of Participants with Adverse Events

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Mobilee yogurt

EXPERIMENTAL

Subjects eating daily on yogurt supplemented with Mobilee

Dietary Supplement: Yogurt supplemented with Mobilee

Placebo yogurt

PLACEBO COMPARATOR

Subjects receiving daily a standard yogurt

Dietary Supplement: Yogurt

Interventions

Yogurt supplemented with MobileeDIETARY_SUPPLEMENT

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

Mobilee yogurt
YogurtDIETARY_SUPPLEMENT

One yogurt (125mL) per day

Placebo yogurt

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43201, Spain

Location

Related Links

MeSH Terms

Interventions

Yogurt

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Officials

  • Rosa Solà, MD

    Hospital Universitari Sant Joan de Reus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 24, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

ES(1)