Recruiting

Inulin

Sponsor:

Ball State University

Code:

NCT07559227

Conditions

Metabolically Healthy Obesity

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Inulin Supplementation

Maltodextrin (Placebo)

High-fat meal

Study Details

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."

Conditions

Metabolically Healthy Obesity

Study ID

NCT07559227

Start date

Mar 1, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Metabolically Healthy Obesity Group

Individuals with a body mass index greater than 30 kg/m2 and 0-1 of the following risk factors: blood pressure >130/85 mmHg, triglycerides > 150 mg/dL, glucose > 100 mg/dL, and HDL-C < 50 (females) or < 40 (males).

active comparator: Metabolically Healthy Normal Weight Group

Individuals with a body mass index between 18.5-24.9 kg/m2 and 0-1 of the following risk factors: blood pressure >130/85 mmHg, triglycerides > 150 mg/dL, glucose > 100 mg/dL, and HDL-C < 50 (females) or < 40 (males).

Interventions

Inulin Supplementation

Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).

Maltodextrin (Placebo)

Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).

High-fat meal

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 outcome measure

  • Serum lipopolysaccharide binding protein [ Time Frame: Through study completion, up to 2 years ]
  • Serum interleukin-6 [ Time Frame: Through study completion, up to 2 years. ]
  • Flow-mediated dilation [ Time Frame: Through study completion, up to 2 years ]
  • Serum C reactive protein [ Time Frame: Through study completion, up to 2 years ]
  • Serum lipopolysaccharide [ Time Frame: Through study completion, up to 2 years ]
  • Serum TNF-alpha [ Time Frame: Through study completion, up to 2 years ]
  • Serum zonulin [ Time Frame: Through study completion, up to 2 years. ]

Central Contacts and Locations

Central contacts

Bryant Keirns, PhD

765-285-8356bryant.keirns@bsu.edu

Locations

Health Professions Building

Recruiting

Muncie, Indiana, United States, 47306

More Information

Sponsor

Ball State University

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Gut-vascular axis
  • Intestinal permeability
  • vascular function
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ball State University on 2026-04-30.