Gut, Immune, and Vascular Health in Metabolically Healthy Obesity
Recruiting · NCT07559227 · Interventional (participants receive a specific treatment) · Lead sponsor: Ball State University
View the official record on ClinicalTrials.gov →Interventions studied
High-fat mealInulin SupplementationMaltodextrin (Placebo)
What this trial is about
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."
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed across 1 US state.
- Health Professions Building - Muncie, Indiana, United States