Methylsulfonylmethane on Knee Laxity

NCT03747198 | Completed

• 1 other identifier: 1356922
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Ligament Injury; Ligament; Laxity; Tendon Rupture; Tendon Injuries

Outcome Measures

Primary Outcomes (1)

• Kneecap displacement (i.e. knee laxity)

  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.

  5 months

Secondary Outcomes (3)

• Weight

  1 day

• Height

  1 day

• Body composition

  1 day

Study Arms (2)

methylsulfonylmethane

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

methylsulfonylmethane DIETARY_SUPPLEMENT

Subjects will be given 2 g/day methylsulfonylmethane.

Also known as: MSM

methylsulfonylmethane

Placebo OTHER

Subjects will be given 2 g/day placebo (rice flour).

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• Bergstrom Nutrition: collaborator

Study Sites (1)

Neurobiology, Physiology & Behaviour

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Joint Instability; Tendon Injuries

Interventions

dimethyl sulfone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: MSM tablets will be packaged and labelled (intervention A or B) by Bergstrom nutrition off-site.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blinded randomized parallel design

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 20, 2018
• Study Start: February 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)