The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

• ClinicalTrials.gov Identifier: NCT03716791
• Recruitment Status: Completed
• First Posted: October 23, 2018
• Last Update Posted: October 5, 2021
• Sponsor: Lindsey Miller
• Information provided by (Responsible Party): Lindsey Miller, Washington State University

Tracking Information

• First Submitted Date: October 18, 2018
• First Posted Date: October 23, 2018
• Last Update Posted Date: October 5, 2021
• Actual Study Start Date: February 19, 2019
• Actual Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2018)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 1, 2019)

• 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.

Original Secondary Outcome Measures (submitted: October 19, 2018)

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health
• Official Title: The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Obesity

Intervention

• Dietary Supplement: methylsulfonylmethane
  3g per day
  Other Name: MSM
• Dietary Supplement: placebo
  white rice flour

Study Arms

• Placebo Comparator: Placebo Control Group
  pill capsules containing white rice flour
  Intervention: Dietary Supplement: placebo
• Active Comparator: Methylsulfonylmethane Group
  pill capsules containing MSM
  Intervention: Dietary Supplement: methylsulfonylmethane

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 4, 2021): 43
• Original Estimated Enrollment (submitted: October 19, 2018): 40
• Actual Study Completion Date: August 11, 2021
• Actual Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03716791
• Other Study ID Numbers: 16970-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lindsey Miller, Washington State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Lindsey Miller
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Washington State University
• Verification Date: October 2021