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New treatment option for Metabolically Healthy Obesity
Official title Gut, Immune, and Vascular Health in Metabolically Healthy Obesity
ClinicalTrials.gov ID: NCT07559227
What this study is testing
- What it's testing
- 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."
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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").
You likely can't join if
- 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).
See the full eligibility 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)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Muncie, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Muncie, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.