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New treatment option for Metabolic Syndrome
Official title Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes
ClinicalTrials.gov ID: NCT07095426
What this study is testing
- What it's testing
- Based on prior research, the investigators are interested in whether an intervention targeting gut health (supplemental fiber for 9 weeks total) will improve vascular health in individuals with obesity. Additionally, the investigators are interested in if this response differs based on whether individuals with obesity have very few heart disease risk factors or several heart disease risk factors.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Participants are 18-55 years old.
- Participants BMI is ≥30 kg/m2 - this BMI requirement is due to our research aims.
- Participants have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides...
- Participants are not pregnant or expecting to become pregnant (females only). Participants are not postmenopausal (females only).
- Participants have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
You likely can't join if
- Participants are not 18-55 years old.
- Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims.
- Participants do not have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar...
- Participants are pregnant or expecting to become pregnant (females only).
- Participants are postmenopausal (females only).
- Participants have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
See the full eligibility criteria
- Participants are 18-55 years old.
- Participants BMI is ≥30 kg/m2 - this BMI requirement is due to our research aims.
- Participants have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
- Participants are not pregnant or expecting to become pregnant (females only). Participants are not postmenopausal (females only).
- Participants have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
- Participants have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis).
- Participants do not regularly take anti-inflammatory drugs (more than 2x week) and are willing to suspend use of these medications for 3 days leading up to in-lab visits.
- Participants do not take weight-loss medications (e.g., Ozempic, Wegovy).
- Participants do not use tobacco products or any illicit drugs.
- Participants have not used antibiotics or probiotics in the last month.
- Participants do not have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
- Participants do not have a pacemaker.
- Participants are able to lie on their back (supine position) in the dark for at least 10 minutes (related to vascular measurements).
- Participants are not 18-55 years old.
- Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims.
- Participants do not have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.
- Participants are pregnant or expecting to become pregnant (females only).
- Participants are postmenopausal (females only).
- Participants have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).
- Participants have been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, diverticulosis/diverticulitis). Participants regularly take anti-inflammatory drugs (more...
- Participants take weight-loss medications (e.g., Ozempic, Wegovy).
- Participants use tobacco products or any illicit drugs.
- Participants have used antibiotics or probiotics in the last month.
- Participants have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance).
- Participants have a pacemaker.
The study team makes the final eligibility decision.
Where it's taking place
- Muncie, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Muncie, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.