Obesity
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTmethylsulfonylmethane
3g per day
DIETARY_SUPPLEMENTplacebo
white rice flour
Sponsors
Lindsey Miller
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Double-blind placebo controlled randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in waist circumference at 4, 8, and 16 weeks | 0,4,8,16 weeks | — |
| Change from baseline insulin at 4, 8, and 16 weeks | 0,4,8,16 weeks | — |
| Change from baseline in pulmonary function tests | 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. |
| Change from baseline in blood markers of inflammation and oxidative stress at 4, 8, and 16 weeks | 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. |
| 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 | — |
Countries
United States
Outcome results
None listed