The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

Obesity Clinical Trial

Official title:

The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716791
• Other study ID #: 16970-001
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: August 11, 2021

Study information

• Verified date: October 2021
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 11, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• methylsulfonylmethane
3g per day
• placebo
white rice flour

Locations

Country	Name	City	State
United States	Washington State University	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Lindsey Miller

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline blood glucose at 4, 8, and 16 weeks		0,4,8,16 weeks
Primary	Change from baseline blood cholesterol at 4, 8, and 16 weeks		0,4,8,16 weeks
Primary	Change from baseline blood pressure at 4, 8, and 16 weeks		0,4,8,16 weeks
Secondary	Change from baseline insulin at 4, 8, and 16 weeks		0,4,8,16 weeks
Secondary	Change from baseline resting metabolic rate at 16 weeks		0 and 16 weeks
Secondary	Change from baseline percent body fat at 4, 8, and 16 weeks		0,4,8,16 weeks
Secondary	Change from baseline in waist circumference at 4, 8, and 16 weeks		0,4,8,16 weeks
Secondary	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
Secondary	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