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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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "At the meal trial, an intravenous catheter will be inserted and baseline blood sample collected."
  • "Following completion of the meal, blood samples will also be collected at 1-, 2-, 3-, 4-, 5-, and 6-hours."
  • "At the baseline assessment, the investigators will collect fasting blood samples to assess biomarkers related to gut, immune, and vascular health."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how one high-fat meal affects the gut, immune system, and blood vessels in adults with obesity or normal weight who have mostly normal heart and blood sugar health. It also tests how inulin, a fiber that feeds gut bacteria, affects adults with obesity.

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."

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–55 years old.
  • For part 1, your BMI is 18.5–24.9 or over 30. For part 2, it is over 30. BMI is a measure based on height and weight.
  • You have no more than 1 risk factor based on blood pressure, blood sugar, blood fats called triglycerides, and HDL (“good”) cholesterol.
  • If female, you are not pregnant, do not expect to become pregnant, and have not gone through menopause.
  • You can eat the study meal without breaking your diet rules or triggering a food allergy.
  • You can lie flat on your back in the dark for at least 10 minutes.

Who can't join

  • You have a serious heart, blood vessel, or blood sugar condition, such as heart disease or type 2 diabetes.
  • You have a long-term condition involving inflammation or the gut, such as rheumatoid arthritis or inflammatory bowel disease.
  • You take drugs for inflammation more than twice a week or cannot stop them for 3 days before the visit. The listing also says stopping may allow you to join; ask the study team to clarify.
  • You have taken antibiotics or probiotics in the past month. Probiotics contain live bacteria.
  • You take medicine to lower cholesterol, blood sugar, or blood pressure, or use weight-loss drugs such as Ozempic or Wegovy.
  • You have had surgery that changes your stomach or gut, such as a gastric sleeve or gastric bypass.
  • You use tobacco or illegal drugs.
  • You have a pacemaker, a device that helps control your heartbeat.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

IN