Tests fiber supplement effects on gut and blood vessel health in obesity
Tests inulin fiber supplements in adults with obesity, with or without metabolic risk factors.
Key facts
- Who runs it
- Ball State University
- Where
- Muncie, United StatesSee the site
- Trial code
- Registry title
- Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 20 May 2025
- Expected to end
- May 2027
- Type of study
- Interventional
- Treatments tested
- inulin
- Record updated
- 31 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-55 with a BMI of 30 kg/m2 or higher. They take a fiber supplement for 9 weeks so researchers can study gut and blood vessel health.
- Age
- 18 to 55 years
- Sex
- All sexes can join.
- Disease stage
- BMI of 30 kg/m2 or higher, with either 0-1 or 2 or more risk factors outside normal ranges: blood pressure, blood sugar, triglycerides, HDL-cholesterol. No advanced heart or metabolic disease such as cardiovascular disease or type 2 diabetes.
- Earlier treatment
- No antibiotics or probiotics in the last month. No weight-loss medications such as Ozempic or Wegovy. No regular anti-inflammatory drugs (more than 2 times a week) unless willing to stop them for 3 days before lab visits.
Main reasons for not taking part
- Pregnant or expecting to become pregnant
- Postmenopausal women
- Advanced heart or metabolic disease, such as cardiovascular disease or type 2 diabetes
- Chronic inflammatory condition, such as rheumatoid arthritis, inflammatory bowel disease or diverticulitis
- Tobacco or illicit drug use, a pacemaker, or a food allergy or intolerance that prevents taking the fiber supplement
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Participants take weight-loss medications (e.g., Ozempic, Wegovy)
- Participants use tobacco products or any illicit drugs
- 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 have dietary restrictions prohibiting them from consuming the fiber supplement (e.g., food allergies/intolerance)
- 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 used antibiotics or probiotics in the last month
- Participants have a pacemaker
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Where in United States
- Health Professions BuildingMuncie, United StatesContact: Bryant Keirns, PhDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Inulin SupplementTreatment being tested
Participants will consume 6g of pre-portioned powdered inulin from chicory root daily for one week followed by 12g daily for eight weeks. Participants will fully dissolve it into a habitual cool or room temperature beverage to drink around the same time each day.
Treatment: inulin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Interplay Between Metabolic Risk Factors, Body Mass Index, and the Gut/Vascular Response to Supplemental Fiber
- Plain-language title
- Tests fiber supplement effects on gut and blood vessel health in obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07095426, who can take part
- Record updated
- 31 July 2025