Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes
Launched by BALL STATE UNIVERSITY · Jul 24, 2025
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether taking a fiber supplement for nine weeks can help improve gut health and blood vessel function in people with obesity. The researchers want to see if these benefits vary depending on how many heart disease risk factors a person has, such as high blood pressure or blood sugar levels. By understanding this, the study hopes to find better ways to support heart and overall health in different groups of people with obesity.
To take part, you need to be between 18 and 55 years old, have a body mass index (BMI) of 30 or higher (which means you are classified as obese), and have either very few (0-1) or several (2 or more) risk factors for heart disease like high blood pressure, blood sugar, or cholesterol levels. Pregnant women, people who use tobacco or certain medications, or those with serious health conditions like heart disease or diabetes cannot join. If eligible, participants will take a fiber supplement daily and attend clinic visits where their blood vessel health will be checked. The study involves simple steps like lying down quietly for a short time during these visits. This trial is currently recruiting volunteers who meet these criteria and are interested in helping researchers learn more about improving health through gut support.
Gender
ALL
Eligibility criteria
- Inclusion 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).
- Exclusion Criteria:
- • 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.
About Ball State University
Ball State University is a distinguished academic institution committed to advancing research and innovation in various fields, including clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its comprehensive resources and expertise to conduct rigorous research that enhances healthcare outcomes. Ball State University fosters an environment of academic excellence, ensuring that all clinical trials adhere to the highest ethical standards while contributing valuable insights to the medical community. Through its dedicated faculty and state-of-the-art facilities, the university aims to drive forward scientific knowledge and improve patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Muncie, Indiana, United States
Patients applied
Trial Officials
Bryant Keirns, PhD
Principal Investigator
Ball State University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported