NCT07559227 Gut, Immune, and Vascular Health in Metabolically Healthy Obesity
| NCT ID | NCT07559227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ball State University |
| Condition | Metabolically Healthy Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-03-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Bryant Keirns, PhD
PRINCIPAL INVESTIGATOR
Ball State University
Frequently Asked Questions
Who can join the NCT07559227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Metabolically Healthy Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07559227 currently recruiting?
Yes, NCT07559227 is actively recruiting participants. Contact the research team at bryant.keirns@bsu.edu for enrollment information.
Where is the NCT07559227 trial being conducted?
This trial is being conducted at Muncie, United States.
Who is sponsoring the NCT07559227 clinical trial?
NCT07559227 is sponsored by Ball State University. The principal investigator is Bryant Keirns, PhD at Ball State University. The trial plans to enroll 70 participants.
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