Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Metabolically Healthy Obesity

In brief

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."

Key facts

Study ID

NCT07559227

Run by

Ball State University

People needed

70

Starts

2026-03-01

Expected to finish

2027-12-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Health Professions Building — Muncie, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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