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OpenTrials
Completed

NCT Number: NCT03716791

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington State University

Spokane, Washington, 99202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methylsulfonylmethane

Dietary Supplement

3g per day

Other names: MSM

Placebo

Dietary Supplement

white rice flour

Primary outcomes

  1. Change from baseline blood glucose at 4, 8, and 16 weeks

    Time frame: 0,4,8,16 weeks

  2. Change from baseline blood cholesterol at 4, 8, and 16 weeks

    Time frame: 0,4,8,16 weeks

  3. Change from baseline blood pressure at 4, 8, and 16 weeks

    Time frame: 0,4,8,16 weeks

Secondary outcomes

  1. Change from baseline insulin at 4, 8, and 16 weeks

    Time frame: 0,4,8,16 weeks

  2. Change from baseline resting metabolic rate at 16 weeks

    Time frame: 0 and 16 weeks

  3. Change from baseline percent body fat at 4, 8, and 16 weeks

    Time frame: 0,4,8,16 weeks

  4. Change from baseline in waist circumference at 4, 8, and 16 weeks

    Time frame: 0,4,8,16 weeks

  5. Change from baseline in blood markers of inflammation and oxidative stress at 4, 8, and 16 weeks

    Time frame: 0,4,8,16 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.

  6. Change from baseline in pulmonary function tests

    Time frame: 0, 4, 8, 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

Lindsey Miller

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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