Low Intensity Knee GonalgiaNCT01303432
Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort
A study testing Yogurt supplemented with Mobilee and Yogurt in people with Low Intensity Knee Gonalgia, run by Bioiberica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Intensity Knee Gonalgia
- What is being tested?
- Yogurt supplemented with Mobilee and Yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Low Intensity Knee Gonalgia
- Being tested
- Yogurt supplemented with Mobilee, Yogurt
- Keywords
- Joint discomfort, Functional Food, Joint function, Mobilee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt supplemented with MobileeDietary supplement
One yogurt (125mL) per day including 80mg of Mobilee
YogurtDietary supplement
One yogurt (125mL) per day
| Study group | Role | What they receive |
|---|---|---|
| Mobilee yogurt | Experimental | Subjects eating daily on yogurt supplemented with Mobilee Receives: Dietary Supplement: Yogurt supplemented with Mobilee |
| Placebo yogurt | Placebo comparator | Subjects receiving daily a standard yogurt Receives: Dietary Supplement: Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 3 months
Pain assessment (VAS)
Time evolution of pain intensity as measured by Visual Analogue Scale (mm).
Measured: 3 months
SF-36 Health questionnaire
Questionnaire SF36-v2 to measure physical and mental health.
Measured: 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
Measured: 3 months
Subjective evaluation of the intervention
Questionnaire to evaluate the subjective perception of the efficacy of the intervention.
Measured: 3 months
Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Intensity Knee GonalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Technological Centre of Nutrition and Health
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, MD, Principal investigator, Hospital Universitari Sant Joan de Reus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303432
- Sponsor's protocol ID
- CTNS 001_03_2010
- Status last verified
- Sep 2012
- First submitted
- 21 Feb 2011
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01303432
- Acronym / sponsor ID
- CTNS 001_03_2010
- Conditions
- Low Intensity Knee Gonalgia
- Keywords
- Joint discomfort, Functional Food, Joint function, Mobilee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Collaborators
- Technological Centre of Nutrition and Health
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilee yogurt | Experimental | Dietary Supplement: Yogurt supplemented with MobileeSubjects eating daily on yogurt supplemented with Mobilee |
| Placebo yogurt | Placebo comparator | Dietary Supplement: YogurtSubjects receiving daily a standard yogurt |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt supplemented with MobileeOne yogurt (125mL) per day including 80mg of Mobilee | Dietary supplement | Mobilee yogurt |
| YogurtOne yogurt (125mL) per day | Dietary supplement | Placebo yogurt |
Primary outcome
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).
7 secondary outcomes
Change from baseline in isokinetic assessment of muscular strength (other conditions)
Time frame: 3 months
Assessment of joint swelling, effusion
Time frame: 3 months
Pain assessment (VAS)
Time frame: 3 months
SF-36 Health questionnaire
Time frame: 3 months
Number of Participants with Adverse Events
Time frame: 3 months
Subjective evaluation of the intervention
Time frame: 3 months
Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Low Intensity Knee Gonalgia
Not yet recruitingPhase 2
Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis
Arthritis, Osteo Arthritis of the Knee
Recruiting
The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain.
Chronic Non-Specific Low Back Pain, Chronic Knee Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Solà, MD principal investigator
Hospital Universitari Sant Joan de Reus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt supplemented with Mobilee and Yogurt in people with Low Intensity Knee Gonalgia, run by Bioiberica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in isokineic assessment of muscular strength (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012.