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

NCT07095426 | Recruiting

• 1 other identifier: IRB-FY2025-75
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Healthy Participants; Metabolically Healthy Obesity; Metabolically Abnormal Obesity

Keywords

fiber; vascular health; gut health; inflammation

Outcome Measures

Primary Outcomes (8)

• Serum Soluble Cluster of Differentiation 14 (sCD14)

  The investigators will measure fasting sCD14 at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  Through study completion, up to 1.5 years.

• Serum Lipopolysaccharide Binding Protein (LBP)

  The investigators will measure fasting LBP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  Through study completion, up to 1.5 years.

• Serum C-Reactive Protein (CRP)

  The investigators will measure fasting CRP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  Through study completion, up to 1.5 years.

• Heart Rate Variability (HRV)

  The investigators will measure HRV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  Through study completion, up to 1.5 years.

• Flow-Mediated Dilation (FMD)

  The investigators will measure FMD at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  Through study completion, up to 1.5 years.

• Pulse Wave Velocity (PWV)

  The investigators will measure PWV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  Through study completion, up to 1.5 years.

• Aortic Aumentation

  The investigators will measure aortic augmentation at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  Through study completion, up to 1.5 years.

• Augmentation Index (AIx)

  The investigators will measure AIx at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

  Through study completion, up to 1.5 years.

Secondary Outcomes (5)

• Blood Pressure

  Through study completion, up to 1.5 years.

• Glucose

  Through study completion, up to 1.5 years.

• High-Density Lipoprotein Cholesterol (HDL-C)

  Through study completion, up to 1.5 years.

• Triglycerides

  Through study completion, up to 1.5 years.

• Digestive Symptoms

  Through study completion, up to 1.5 years.

Other Outcomes (1)

• Body Composition

  Through study completion, up to 1.5 years.

Study Arms (1)

Inulin Supplement

EXPERIMENTAL

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.

Dietary Supplement: inulin

Interventions

inulin DIETARY_SUPPLEMENT

6g inulin from chicory root per day for one week and 12g inulin per day for eight weeks dissolved into cool or room temperature liquid

Inulin Supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Ball State University: lead

Study Sites (1)

Health Professions Building

Muncie, Indiana, 47306, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Obesity, Metabolically Benign; Inflammation

Interventions

Inulin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Bryant Keirns, PhD

  Ball State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryant Keirns, PhD

CONTACT

765-285-8356; bryant.keirns@bsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single arm, open label

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)