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Impaired Gut-Vascular Axis as a Unique Driver of Cardiovascular Disease in Metabolically Healthy Obesity

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators seek to better understand how a single high-fat meal impacts gut, immune, and vascular outcomes in individuals with metabolically healthy obesity (obesity and largely normal cardiometabolic profile) and metabolically healthy normal-weight individuals. Second, the investigators seek to understand how a prebiotic fiber (inulin) impacts gut, immune, and vascular outcomes in individuals with metabolically healthy obesity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 18-55 years old.

• BMI is 18.5-24.9 kg/m2 or \>30kg/m2 (part 1). BMI \> 30 kg/m2 (part 2)

• Not pregnant or expecting to become pregnant (females only).

• Not postmenopausal (females only).

• Have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol (good cholesterol).

• Have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).

• Have not been diagnosed with a chronic inflammatory or gastrointestinal condition (e.g., rheumatoid arthritis, inflammatory bowel disease).

• Do not regularly take anti-inflammatory drugs (more than 2x week) or are able to temporarily suspend use of anti-inflammatory drugs three days prior to the study visit.

• Have not taken antibiotics or probiotics in the last month.

• Do not use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin), or anti-hypertensive drugs.

• Do not use weight-loss drugs (e.g., Ozempic, Wegovy).

• Have not had any surgery that alters the stomach/gastrointestinal tract (e.g., gastric sleeve, gastric bypass).

• Do not use tobacco products or any illicit drugs.

• Do not have a pacemaker.

• Do not have dietary restrictions prohibiting consumption of the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies).

• Able to stay in the supine position in the dark for at least 10 minutes (related to vascular measurements)

Locations
United States
Indiana
Health Professions Building
RECRUITING
Muncie
Contact Information
Primary
Bryant Keirns, PhD
bryant.keirns@bsu.edu
765-285-8356
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 70
Treatments
Experimental: Metabolically Healthy Obesity Group
Individuals with a body mass index greater than 30 kg/m2 and 0-1 of the following risk factors: blood pressure \>130/85 mmHg, triglycerides \> 150 mg/dL, glucose \> 100 mg/dL, and HDL-C \< 50 (females) or \< 40 (males).
Active_comparator: Metabolically Healthy Normal Weight Group
Individuals with a body mass index between 18.5-24.9 kg/m2 and 0-1 of the following risk factors: blood pressure \>130/85 mmHg, triglycerides \> 150 mg/dL, glucose \> 100 mg/dL, and HDL-C \< 50 (females) or \< 40 (males).
Related Therapeutic Areas
Sponsors
Leads: Ball State University

This content was sourced from clinicaltrials.gov