ObesityNCT03716791
The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health
A study testing methylsulfonylmethane in people with Obesity, run by Lindsey Miller at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- methylsulfonylmethane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2019to 11 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University
Spokane, Washington, 99202
About this study
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
- Being tested
- methylsulfonylmethane, placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylsulfonylmethaneDietary supplement
Also called MSM
3g per day
placeboDietary supplement
white rice flour
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control Group | Placebo comparator | pill capsules containing white rice flour Receives: Dietary Supplement: placebo |
| Methylsulfonylmethane Group | Active comparator | pill capsules containing MSM Receives: Dietary Supplement: methylsulfonylmethane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline blood glucose at 4, 8, and 16 weeks
Measured: 0,4,8,16 weeks
Change from baseline blood cholesterol at 4, 8, and 16 weeks
Measured: 0,4,8,16 weeks
Change from baseline blood pressure at 4, 8, and 16 weeks
Measured: 0,4,8,16 weeks
Secondary outcomes (6)
Change from baseline insulin at 4, 8, and 16 weeks
Measured: 0,4,8,16 weeks
Change from baseline resting metabolic rate at 16 weeks
Measured: 0 and 16 weeks
Change from baseline percent body fat at 4, 8, and 16 weeks
Measured: 0,4,8,16 weeks
Change from baseline in waist circumference at 4, 8, and 16 weeks
Measured: 0,4,8,16 weeks
Change from baseline in blood markers of inflammation and oxidative stress at 4, 8, and 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.
Measured: 0,4,8,16 weeks
Change from baseline in pulmonary function tests
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.
Measured: 0, 4, 8, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start19 Feb 2019
- Primary completion30 Jan 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo controlled randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindsey Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lindsey Miller, Washington State University
- Investigators
- Lindsey E Miller, Ph.D, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716791
- Sponsor's protocol ID
- 16970-001
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Methylsulfonylmethane (MSM) on Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT03716791
- Acronym / sponsor ID
- 16970-001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Lindsey MillerUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind placebo controlled randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo Control Group | Placebo comparator | Dietary Supplement: placebopill capsules containing white rice flour |
| Methylsulfonylmethane Group | Active comparator | Dietary Supplement: methylsulfonylmethanepill capsules containing MSM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylsulfonylmethaneAlso: MSM3g per day | Dietary supplement | Methylsulfonylmethane Group |
| placebowhite rice flour | Dietary supplement | Placebo Control Group |
Primary outcome
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
6 secondary outcomes
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
Change from baseline in pulmonary function tests
Time frame: 0, 4, 8, 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey E Miller, Ph.D principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylsulfonylmethane in people with Obesity, run by Lindsey Miller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline blood glucose at 4, 8, and 16 weeks (time frame: 0,4,8,16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.