The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

Obesity- related diseases are linked to elevated levels of inflammation, oxidative stress, and metabolic dysfunction. Methylsulfonylmethane (MSM) is a naturally occurring compound that demonstrates antioxidant and anti-inflammatory effects. Improvements in measures of metabolic health have been observed in mouse models of obesity and type 2 diabetes following MSM treatment. However, the effect of MSM on obesity-related risk factors for disease in humans has not been investigated. Therefore, the purpose of this investigation will be to determine whether MSM supplementation improves metabolic health, and markers of inflammation and oxidative status.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: methylsulfonylmethane

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Washington State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• overweight or obese adults without any diagnosed disease or current medications other than birth control. Participants must agree to maintain diet and physical activity levels throughout study.

Exclusion Criteria:

• normal weight adults, or overweight/obese adults that do not meet the criteria for metabolically unhealthy obesity. Individuals currently on medications, or with diagnosed disease. Pregnant or nursing women, or women planning to become pregnant within the study timeframe. Lack of access to reliable transportation to study site, lack of internet access, or non-english speaking.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control Group; pill capsules containing white rice flour	Dietary supplement: placebo; white rice flour
Active Comparator: Methylsulfonylmethane Group; pill capsules containing MSM	Dietary supplement: methylsulfonylmethane; 3g per day; Other Names: MSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline blood glucose at 4, 8, and 16 weeks	0,4,8,16 weeks
Change from baseline blood cholesterol at 4, 8, and 16 weeks	0,4,8,16 weeks
Change from baseline blood pressure at 4, 8, and 16 weeks	0,4,8,16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline insulin at 4, 8, and 16 weeks		0,4,8,16 weeks
Change from baseline resting metabolic rate at 16 weeks		0 and 16 weeks
Change from baseline percent body fat at 4, 8, and 16 weeks		0,4,8,16 weeks
Change from baseline in waist circumference at 4, 8, and 16 weeks		0,4,8,16 weeks
Change from baseline in blood markers of inflammation and oxidative stress at 4, 8, and 16 weeks	Inflammatory markers will include c-reactive protein, interleukin-6, and Tumor necrosis factor-alpha. Oxidative stress will be determined by total antioxidant capacity assay.	0,4,8,16 weeks
Change from baseline in pulmonary function tests	Pulmonary function tests include forced expiratory volume in 1 second to forced vital capacity ration and slow vital capacity measurement. Expired nitric oxide has also been included as a marker of pulmonary inflammation.	0, 4, 8, 16 weeks

Collaborators and Investigators

• Sponsor: Lindsey Miller
• Investigators: Principal Investigator: Lindsey E Miller, Ph.D, Washington State University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): August 11, 2021

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Dimethyl sulfone
• Other Study ID Numbers: 16970-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No