The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health

NCT03716791 | Completed

• 1 other identifier: 16970-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change from baseline insulin at 4, 8, and 16 weeks

  0,4,8,16 weeks

• 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

• Change from baseline in waist circumference at 4, 8, and 16 weeks

  0,4,8,16 weeks

• Change from baseline in blood markers of inflammation and oxidative stress at 4, 8, and 16 weeks

  0,4,8,16 weeks

Study Arms (2)

Placebo Control Group

PLACEBO COMPARATOR

pill capsules containing white rice flour

Dietary Supplement: placebo

Methylsulfonylmethane Group

ACTIVE COMPARATOR

pill capsules containing MSM

Dietary Supplement: methylsulfonylmethane

Interventions

methylsulfonylmethane DIETARY_SUPPLEMENT

3g per day

Also known as: MSM

Methylsulfonylmethane Group

placebo DIETARY_SUPPLEMENT

white rice flour

Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindsey Miller: lead

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

dimethyl sulfone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lindsey E Miller, Ph.D

  Washington State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Double-blind placebo controlled randomized controlled trial

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 23, 2018
• Study Start: February 19, 2019
• Primary Completion: January 30, 2021
• Study Completion: August 11, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)