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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
Sponsor:
Collaborator:
Bergstrom Nutrition
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: methylsulfonylmethane
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).
Other: Placebo
Subjects will be given 2 g/day placebo (rice flour).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female menstruate and the study is base on hormonal fluctuations that happen concurrent to the menstrual cycle and the effects of estrogen on knee laxity. This is why the study is including only females.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Regular menstrual cycle (~1 x month)

    • Not using oral contraceptive
    • No history of serious knee injury (e.g. ACL rupture)
    • Not currently pregnant (known)
    • Not routinely taking medication or supplements that would interact with study measures or be contraindicated (e.g. steroid injections)

Exclusion Criteria:

  • • Irregular menstrual cycling (1 x month)

    • Using oral contraceptive
    • History of serious knee injury (e.g. ACL rupture)
    • Currently pregnant or potential of being pregnant
    • Routinely taking medication or supplements that would interact with study measures or be contraindicated (e.g. steroid injections)

Information from the National Library of Medicine

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


Locations
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United States, California
Neurobiology, Physiology & Behaviour Recruiting
Davis, California, United States, 95616
Contact: Keith Baar, PhD    530-400-2188    kbaar@ucdavis.ecu   
Contact: Dana M Lis, PhD    530-304-5873    dmlis@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Bergstrom Nutrition

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03747198     History of Changes
Other Study ID Numbers: 1356922
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Rupture
Tendon Injuries
Dimethyl sulfone
Dimethyl Sulfoxide
Anti-Inflammatory Agents
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action