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Understanding Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

This study aims to understand how a high-fat meal affects your gut, immune system, and blood vessels if you have "metabolically healthy obesity" (obesity with generally normal heart and metabolic health) or a normal weight. Researchers also want to see if a fiber supplement called inulin can improve these outcomes for people with metabolically healthy obesity. The study will measure specific markers in your blood, like lipopolysaccharide binding protein and interleukin-6, and assess blood vessel function (flow-mediated dilation) over up to two years. You might be eligible if you are 18-55 years old, not pregnant, and have 0-1 risk factors for metabolic syndrome. The study plans to enroll 70 participants, but its current status is unclear.

Study design
This interventional study has two parts, enrolling 70 participants. Half of the participants in part 2 will receive either inulin or a placebo (maltodextrin).
What's involved
You will have a screening visit to check your metabolic health. If eligible, you will complete one meal trial where you consume a high-fat meal, have an intravenous catheter inserted, and provide blood samples at several time points over 6 hours. Vascular assessments will also be performed.
Compensation
Not stated in the trial record.
Follow-up
Your blood markers and blood vessel function will be measured through study completion, which can be up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07559227

Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

Recruiting
NAAges 18–55Interventional
Ball State University
~70 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Inulin SupplementationMaltodextrin (Placebo)High-fat meal

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serum lipopolysaccharide binding protein
Measured over Through study completion, up to 2 years
+6 more outcomes measured

Conditions

Metabolically Healthy Obesity

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Bryant Keirns, PhD · PRINCIPAL_INVESTIGATOR · Ball State University

Who to contact

Bryant Keirns, PhD
[email protected]
765-285-8356
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Serum lipopolysaccharide binding proteinThrough study completion, up to 2 years

    Part 1: The investigators will measure lipopolysaccharide binding protein at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure lipopolysaccharide binding protein at baseline and 2-, 4-, and 6-weeks post intervention.

  • Serum interleukin-6Through study completion, up to 2 years.

    Part 1: The investigators will measure interleukin-6 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure interleukin-6 at baseline and 2-, 4-, and 6-weeks post intervention.

  • Flow-mediated dilationThrough study completion, up to 2 years

    Part 1: The investigators will measure flow-mediated dilation at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure flow-mediated dilation at baseline and 2-, 4-, and 6-weeks post intervention.

  • Serum C reactive proteinThrough study completion, up to 2 years

    Part 2: The investigators will measure C reactive protein at baseline and 2-, 4-, and 6-weeks post intervention.

  • Serum lipopolysaccharideThrough study completion, up to 2 years

    Part 1: The investigators will measure lipopolysaccharide at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure lipopolysaccharide at baseline and 2-, 4-, and 6-weeks post intervention.

  • Serum TNF-alphaThrough study completion, up to 2 years

    The investigators will measure serum TNF-alpha at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure TNF-alpha at baseline and 2-, 4-, and 6-weeks post intervention.

  • Serum zonulinThrough study completion, up to 2 years.

    Part 2: The investigators will measure serum zonulin at baseline and 2-, 4-, and 6-weeks post intervention.