The Effects of Methylsulfonylmethane on Knee Laxity in Active Young Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Kneecap displacement (i.e. knee laxity)
研究概览
简要总结
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.
详细描述
Familiarization: Subjects would come to the Human Performance lab for a study orientation to be informed of the goals of the study, have anthropometric data collected (InBody770, In Body, Cerritos, CA) and familiarized with all testing and data collection tools. The purpose of this is to collect anthropometric data, review the study procedures and study requirements.
Determination of menstruation date: After study familiarization instructions will be given to contact the research team and come back to the lab on the first day of menstruation to establish the individual study timeline. An ovulation kit will be provided. The ovulation kit would then be started at the end of the first reported menstrual cycle and be used daily until the 2-4 days of high estrogen (ovulation) are established.
Baseline data: After menstruation date is established, for the first two months of the study, subjects would come to the lab on the first day of menstruation and the day after ovulation, have their knee laxity measured (GNRB dynamic laximeter, Prothia, Worcester, MA) and salivary analysis to determine estrogen levels. The first two months would determine normal changes in knee laxity and estrogen levels throughout the cycle within each subject.
Intervention: Following the second ovulation testing day and once baseline values are established, subjects would be provided with 3 months of MSM or placebo control (rice flour) and instructed to take 2g each morning for the subsequent 3 months. Month 3 would serve as an MSM loading month and subjects would return to the laboratory throughout months 4 and 5 (day 14 and first day of menstruation) for mechanical and estrogen testing.
MSM or placebo treatments: The study will be a randomized double-blinded placebo-controlled trial. MSM or placebo capsules would be provided in a double blinded manner following the second mechanical test. Each individual would consume 2g of either the MSM or placebo control for the remainder of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
MSM tablets will be packaged and labelled (intervention A or B) by Bergstrom nutrition off-site.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• 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)
排除标准
- •• 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)
结局指标
主要结局
Kneecap displacement (i.e. knee laxity)
时间窗: 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.
次要结局
- Weight(1 day)
- Height(1 day)
- Body composition(1 day)