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RECRUITING

NCT07559227

Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

Sponsor: Ball State University

View on ClinicalTrials.gov

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."

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-01

Completion Date

2027-12

Last Updated

2026-04-30

Healthy Volunteers

Yes

Conditions

Metabolically Healthy Obesity

Interventions

DIETARY_SUPPLEMENT

Inulin Supplementation

Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).

DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).

OTHER

High-fat meal

All participants in part 1 (both metabolically healthy normal weight and metabolically healthy obesity) will consume a high-fat meal designed to invoke changes in gut, immune, and vascular parameters.

Inclusion Criteria: * 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) Exclusion Criteria: * Not 18-55 years old. * BMI is not 18.5-24.9 kg/m2 or \>30kg/m2 (part 1). BMI is not \> 30 kg/m2 (part 2) * Pregnant or expecting to become pregnant (females only). * Postmenopausal (females only). * Do not have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol ("good cholesterol"). * Have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes). * Have been diagnosed with a chronic inflammatory or gastrointestinal condition (e.g., rheumatoid arthritis, inflammatory bowel disease). * Regularly take anti-inflammatory drugs (more than 2x week) or are unable to temporarily suspend use of anti-inflammatory drugs three days prior to the study visit. * Have taken antibiotics or probiotics in the last month. * Use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin), or anti-hypertensive drugs. * Use weight-loss drugs (e.g., Ozempic, Wegovy). * Have had any surgery that alters the stomach/gastrointestinal tract (e.g., gastric sleeve, gastric bypass). * Use tobacco products or any illicit drugs. * Have a pacemaker. * Have dietary restrictions prohibiting consumption of the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies). * Not able to stay in the supine position in the dark for at least 10 minutes (related to vascular measurements)

Locations (1)

Health Professions Building

Muncie, Indiana, United States