The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: methylsulfonylmethane
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind placebo controlled randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control Group<br>pill capsules containing white rice flour | Dietary Supplement: placebo<br>* white rice flour<br>|
| Active Comparator: Methylsulfonylmethane Group<br>pill capsules containing MSM | Dietary Supplement: methylsulfonylmethane<br>* 3g per day<br>* Other names: MSM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |