Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes

Recruiting now · Not applicable

Conditions studied: Metabolic Syndrome, Healthy Participants, Metabolically Healthy Obesity, Metabolically Abnormal Obesity

In brief

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.

Key facts

Study ID

NCT07095426

Run by

Ball State University

People needed

20

Starts

2025-05-20

Expected to finish

2027-05-01

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify 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, 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).

You may not qualify 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, 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 than 2x week) and are not willing to suspend use of these medications for 3 days leading up to in-lab visits.
• 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.

Where it is running

• Health Professions Building — Muncie, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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