The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health
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ClinicalTrials.gov Identifier: NCT03716791 |
Recruitment Status :
Completed
First Posted : October 23, 2018
Last Update Posted : October 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Dietary Supplement: methylsulfonylmethane Dietary Supplement: placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 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 |
Actual Primary Completion Date : | January 30, 2021 |
Actual Study Completion Date : | August 11, 2021 |
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 |
- Change from baseline blood glucose at 4, 8, and 16 weeks [ Time Frame: 0,4,8,16 weeks ]
- Change from baseline blood cholesterol at 4, 8, and 16 weeks [ Time Frame: 0,4,8,16 weeks ]
- Change from baseline blood pressure at 4, 8, and 16 weeks [ Time Frame: 0,4,8,16 weeks ]
- Change from baseline insulin at 4, 8, and 16 weeks [ Time Frame: 0,4,8,16 weeks ]
- Change from baseline resting metabolic rate at 16 weeks [ Time Frame: 0 and 16 weeks ]
- Change from baseline percent body fat at 4, 8, and 16 weeks [ Time Frame: 0,4,8,16 weeks ]
- Change from baseline in waist circumference at 4, 8, and 16 weeks [ Time Frame: 0,4,8,16 weeks ]
- 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.
- 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 |
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.
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
United States, Washington | |
Washington State University | |
Spokane, Washington, United States, 99202 |
Principal Investigator: | Lindsey E Miller, Ph.D | Washington State University |
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 5, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dimethyl sulfone Anti-Inflammatory Agents |