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The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

Sponsor
Lindsey Miller (Other)
Overall Status
Completed
CT.gov ID
NCT03716791
Collaborator
(none)
43
Enrollment
1
Location
2
Arms
29.7
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: methylsulfonylmethane
  • Dietary Supplement: placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blind placebo controlled randomized controlled trialDouble-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 :
Feb 19, 2019
Actual Primary Completion Date :
Jan 30, 2021
Actual Study Completion Date :
Aug 11, 2021

Arms and Interventions

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 Names:
  • MSM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline blood glucose at 4, 8, and 16 weeks [0,4,8,16 weeks]

    2. Change from baseline blood cholesterol at 4, 8, and 16 weeks [0,4,8,16 weeks]

    3. Change from baseline blood pressure at 4, 8, and 16 weeks [0,4,8,16 weeks]

    Secondary Outcome Measures

    1. Change from baseline insulin at 4, 8, and 16 weeks [0,4,8,16 weeks]

    2. Change from baseline resting metabolic rate at 16 weeks [0 and 16 weeks]

    3. Change from baseline percent body fat at 4, 8, and 16 weeks [0,4,8,16 weeks]

    4. Change from baseline in waist circumference at 4, 8, and 16 weeks [0,4,8,16 weeks]

    5. 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.

    6. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington State University Spokane Washington United States 99202

    Sponsors and Collaborators

    • Lindsey Miller

    Investigators

    • Principal Investigator: Lindsey E Miller, Ph.D, Washington State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lindsey Miller, Assistant Professor, Washington State University
    ClinicalTrials.gov Identifier:
    NCT03716791
    Other Study ID Numbers:
    • 16970-001
    First Posted:
    Oct 23, 2018
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dimethyl sulfone

    Study Results

    No Results Posted as of Oct 5, 2021