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The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716791
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Lindsey Miller, Washington State University

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: methylsulfonylmethane Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind placebo controlled randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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 Name: MSM




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716791


Contacts
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Contact: Lindsey E Miller, Ph.D 509-368-6733 ext 5093686733 lindsey.e.miller@wsu.edu

Locations
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United States, Washington
Washington State University Recruiting
Spokane, Washington, United States, 99202
Contact: Malathi Jandhyala    509-335-3668    irb@wsu.edu   
Sponsors and Collaborators
Lindsey Miller
Investigators
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Principal Investigator: Lindsey E Miller, Ph.D Washington State University

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Responsible Party: Lindsey Miller, Assistant Professor, Washington State University
ClinicalTrials.gov Identifier: NCT03716791    
Other Study ID Numbers: 16970-001
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dimethyl sulfone
Dimethyl Sulfoxide
Anti-Inflammatory Agents
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action