Gut, Immune, and Vascular Health in Metabolically Healthy Obesity
Impaired Gut-Vascular Axis as a Unique Driver of Cardiovascular Disease in Metabolically Healthy Obesity
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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)About the study
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."
What is being tested
- Inulin Supplementation (dietary supplement)
- Maltodextrin (Placebo) (dietary supplement)
- High-fat meal (other)
Sponsor: Ball State University · Participants: 70 · Started: Mar 1, 2026
Contact the study team
- Bryant Keirns, PhD · Phone: 765-285-8356
Official record on ClinicalTrials.gov — NCT07559227
Locations in the U.S.
| Indiana | Health Professions Building, Muncie |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.