Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

Part of paid clinical trials in Muncie, Indiana.

Sponsor
Ball State University
Study ID
NCT07559227
Status
Recruiting
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Conditions

  • Metabolically Healthy Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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."

Key Dates

Start date
Mar 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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).

Primary Outcome Measure

Serum lipopolysaccharide binding protein [ Time Frame: Through study completion, up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Health Professions BuildingMuncieIndiana47306-

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Health Professions Building· Muncie, IN

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