Methylsulfonylmethane on Knee Laxity
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|ClinicalTrials.gov Identifier: NCT03747198|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : March 1, 2019
The proposed research will focus on determining the effect of methylsulfonylmethane (MSM) on knee laxity changes through the menstrual cycle in young active females.
As an extension to recent discovery, that MSM reverses the negative effect of estrogen on engineered ligament function, the proposed work is designed to determine whether MSM can decrease the negative effect of estrogen on knee laxity in females.
Ligament function is determined by the content and cross-linking of collagen, which is influenced by a milieu of biochemical and mechanical parameters. The greater the amount and cross-linking the greater the stiffness and strength of these connective tissues. In engineered ligaments it has been previously shown that the high levels of estrogen, normally present in the days before and after ovulation, can inhibit the cross-linking enzyme lysyl oxidase. This decrease in collagen cross-linking likely increases connective tissue laxity and contributes to observed 4-fold greater occurrence of anterior cruciate ligament (ACL) rupture in females. Conversely, MSM increases collagen cross-linking and recent work conducted by the Baar lab in engineered human ligaments treated with high estrogen demonstrated that MSM could completely reverse the effects of estrogen on ligament mechanics.
The proposed research aims to advance this promising pre-clinical data and apply in a clinical trial. This research also proposes to quantify that knee laxity increases up to 5mm between the first day of menstruation and the day after ovulation and also that the magnitude of the increase in laxity is directly related to the magnitude of the change in estrogen. Importantly, a direct relationship between knee laxity and ACL rupture exists. For every 1.3mm increase in anterior-posterior knee displacement, the odds of ACL rupture increase 4-fold. Therefore, any treatment that decreases knee laxity could be expected to reduce ACL ruptures and have widespread application across the general active population and high-level athletics.
|Condition or disease||Intervention/treatment||Phase|
|Ligament Injury Ligament; Laxity Tendon Rupture Tendon Injuries||Dietary Supplement: methylsulfonylmethane Other: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double blinded randomized parallel design|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||MSM tablets will be packaged and labelled (intervention A or B) by Bergstrom nutrition off-site.|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effects of Methylsulfonylmethane on Knee Laxity in Active Young Females|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Subjects will be given 2 g/day of methylsulfonylmethane (MSM). Salivary estrogen will be measured around ovulation and menstruation each month for 3 months. Knee laxity will be measures 2 times per month at the same time points (ovulation, menstruation).
Dietary Supplement: methylsulfonylmethane
Subjects will be given 2 g/day methylsulfonylmethane.
Other Name: MSM
Placebo Comparator: Placebo
Subjects will be given 2 g/day placebo (rice flour). Salivary estrogen will be measured around ovulation and menstruation each month for 3 months. Knee laxity will be measures 2 times per month at the same time points as the intervention arm (ovulation, menstruation).
Subjects will be given 2 g/day placebo (rice flour).
- Kneecap displacement (i.e. knee laxity) [ Time Frame: 5 months ]Knee laxity will be measured at months 4 and 5 after the 3-month intervention period of the study. The measurement will be made in millimeters using a specially designed GNRB arthrometer, which is a computerized and automatic medical device developed and validated by Genourob.
- Weight [ Time Frame: 1 day ]The subjects weight (kg) will be commented at the start of the study for subject demographic purposes. Measurements will be made with the InBody 570 Body Composition analyzer.
- Height [ Time Frame: 1 day ]The subjects height (cm) will be commented at the start of the study for subject demographic purposes. Measurements will be made with a stadiometer.
- Body composition [ Time Frame: 1 day ]The subjects body composition (% body fat) will be commented at the start of the study for subject demographic purposes. Measurements will be made with the InBody 570 Body Composition analyzer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747198
|United States, California|
|Neurobiology, Physiology & Behaviour||Recruiting|
|Davis, California, United States, 95616|
|Contact: Keith Baar, PhD 530-400-2188 firstname.lastname@example.org|
|Contact: Dana M Lis, PhD 530-304-5873 email@example.com|