Recruiting nowNot applicableInterventional
What this study 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."
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionMetabolically Healthy Obesity
Full registry 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)
Treatments and study arms
Inulin Supplementation
Dietary Supplement
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Maltodextrin (Placebo)
Dietary Supplement
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
High-fat meal
Other
All participants in part 1 (both metabolically healthy normal weight and metabolically healthy obesity) will consume a high-fat meal designed to invoke changes in gut, immune, and vascular parameters.
Primary outcomes
Serum lipopolysaccharide binding proteinThrough study completion, up to 2 yearsPart 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 yearsPart 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 yearsPart 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 yearsPart 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 yearsThe 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.
