Gut, Immune, and Vascular Health in Metabolically Healthy Obesity
Impaired Gut-Vascular Axis as a Unique Driver of Cardiovascular Disease in Metabolically Healthy Obesity
Ball State University
70 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria16
- -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 Criteria16
- 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)
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Interventions
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07559227