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NCT07559227Recruiting

Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

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

Source: ClinicalTrials.gov · Last updated 30 Apr 2026

Brief summary (registry, in English)

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."

Status (registry)
Recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
16 Apr 2026
Start date
Mar 2026
Primary completion date
Dec 2027
Lead sponsor
Ball State University
Diseases
Obesity
NCT number
NCT07559227

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From Mar 2026 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • 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).
  • Have dietary restrictions prohibiting consumption of the provided meal (e.g., vegan/vegetarian diets, gluten-free diet, relevant food allergies).

Lab values

  • Use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin), or anti-hypertensive drugs.

Age

  • Not 18-55 years old.

Other

  • 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 taken antibiotics or probiotics in the last month.
  • Have a pacemaker.
  • Not able to stay in the supine position in the dark for at least 10 minutes (related to vascular measurements)

Who the study is looking for

  • 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)

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Health Professions Building
Coordinator of this site? Confirm its status
MuncieUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.