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Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

23 avril 2026 mis à jour par: Bryant Keirns, Ball State University

Impaired Gut-Vascular Axis as a Unique Driver of Cardiovascular Disease in Metabolically Healthy Obesity

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."

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This study consists of two parts (part 1 and part 2) that are approved under the same IRB approval code. As a result, there is only one unique identifier for the entirety of this project. As a results, the investigators have included both parts in this registration.

Part 1 of project:

The investigators will recruit individuals with a BMI in the normal (18.5-24.9 kg/m2) or obesity (>30.0 kg/m2) ranges from the Ball State University campus and surrounding communities. At a screening visit, the investigators will measure metabolic syndrome risk (blood pressure, triglycerides, glucose, HDL-C) to see if individuals meet criteria for "metabolically healthy obesity" and "metabolically healthy normal-weight" - our two groups of interest.

Each participant will complete one meal trial. At the meal trial, an intravenous catheter will be inserted and baseline blood sample collected. Next, vascular assessments (i.e., flow mediated dilation [FMD], pulse wave analysis [PWA], pulse wave velocity [PWV]) will be completed. Then, participants will consume the high-fat meal consisting of heavy cream, chocolate syrup, and protein powder. The meal will contain ~700 calories (55g fat).

Following completion of the meal, blood samples will also be collected at 1-, 2-, 3-, 4-, 5-, and 6-hours. At each time point the investigators will collect serum to assess biomarkers of intestinal permeability and inflammation. Serum will also be used in mechanistic experiments where the investigators will treat endothelial cells in culture with serum from participants pre/post high-fat meal and examine differences in gene and protein expression, as well as nitric oxide production. Additional blood will be collected for peripheral blood mononuclear cell isolation at baseline and 3 hours. Vascular assessments listed above will be repeated at 2-, 4-, and 6-hours.

Participants will provide a stool sample collected at home for microbiome analyses.

Part 2 of project:

The investigators will recruit individuals with a BMI in the obesity (>30.0 kg/m2) range from the Ball State University campus and surrounding communities. At a screening visit, the investigators will measure metabolic syndrome risk (blood pressure, triglycerides, glucose, HDL-C) to see if individuals meet criteria for "metabolically healthy obesity" - our sole group of interest.

Qualifying participants will report for a baseline assessment. At the baseline assessment, the investigators will collect fasting blood samples to assess biomarkers related to gut, immune, and vascular health. Serum will also be used in mechanistic experiments where the investigators will treat endothelial cells in culture with serum from participants pre/post intervention and examine differences in gene and protein expression, as well as nitric oxide production. Next, vascular assessments (i.e., flow mediated dilation [FMD], pulse wave analysis [PWA], pulse wave velocity [PWV]) will be completed. This will conclude data collection and participants will be randomized to receive 6 weeks of supplemental inulin (a soluble fiber) or a placebo (maltodextrin). At 2-, 4-, and 6-weeks of the intervention, the same samples and measurements will be collected at in-lab visits. Stool samples will be collected at baseline and 6 weeks.

Type d'étude

Interventionnel

Inscription (Estimé)

70

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Indiana
      • Muncie, Indiana, États-Unis, 47306
        • Recrutement
        • Health Professions Building

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Complément alimentaire: Inulin Supplementation
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Complément alimentaire: Maltodextrin (Placebo)
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Autre: 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.
Comparateur actif: 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).
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Serum lipopolysaccharide binding protein
Délai: Through study completion, up to 2 years

Part 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.
Through study completion, up to 2 years
Serum interleukin-6
Délai: Through 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.
Through study completion, up to 2 years.
Flow-mediated dilation
Délai: Through study completion, up to 2 years
Part 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.
Through study completion, up to 2 years
Serum C reactive protein
Délai: Through study completion, up to 2 years
Part 2: The investigators will measure C reactive protein at baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to 2 years
Serum lipopolysaccharide
Délai: Through study completion, up to 2 years
Part 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.
Through study completion, up to 2 years
Serum TNF-alpha
Délai: Through study completion, up to 2 years
The 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.
Through study completion, up to 2 years
Serum zonulin
Délai: Through study completion, up to 2 years.
Part 2: The investigators will measure serum zonulin at baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to 2 years.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Augmentation Index
Délai: Through study completion, up to 2 years
Part 1: The investigators will measure augmentation index at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure augmentation index at baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to 2 years
Pulse-wave velocity
Délai: Through study completion, up to 2 years
Part 1: The investigators will measure pulse-wave velocity at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure pulse wave velocity at baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to 2 years
Serum soluble CD14
Délai: Through study completion, up to 2 years
Part 1: The investigators will measure serum soluble CD14 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure serum soluble sCD14 at baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to 2 years
Serum IL-1 beta
Délai: Through study completion, up to 2 years
Part 1: The investigators will measure serum IL-1 beta at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure serum IL-1beta at baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to 2 years
Serum soluble VCAM-1
Délai: Through study completion, up to 2 years
Part 1: The investigators will measure serum soluble VCAM-1 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal.
Through study completion, up to 2 years
Peripheral blood mononuclear cell transcriptome
Délai: Through study completion, up to 2 years
Part 1: The investigators will measure interleukin-6 at baseline and 3-hours after the meal.
Through study completion, up to 2 years
Serum treated HAEC transcriptome
Délai: Through study completion, up to 2 years
Part 1: The investigators will measure the HAEC transcriptome after treatment with baseline and 2-, 4-, 6-hour post-meal serum. Part 2: The investigators will measure the HAEC transcriptome after treatment with serum from baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to 2 years
Serum treated HAEC eNOS and NFkB protein expression
Délai: Through study completion, up to 2 years
Part 1: The investigators will measure HAEC eNOS and NFkB protein expression after treatment with baseline and 2-, 4-, 6-hour post-meal serum. Part 2: The investigators will measure HAEC eNOS and NFkB protein expression after treatment with serum from baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to 2 years
Microbiome composition (shotgun sequencing)
Délai: Through study completion, up to 2 years
Part 1: The investigators will determine microbiome composition once within one week of participants completing the meal trial. Part 2: The investigators will measure microbiome composition at baseline and 6-weeks post intervention.
Through study completion, up to 2 years
Serum treated HAEC nitric oxide production
Délai: Through study completion, up to two years.
Part 1: The investigators will measure the HAEC nitric oxide production after treatment with baseline and 2-, 4-, 6-hour post-meal serum. Part 2: The investigators will measure HAEC nitric oxide production after treatment with serum from baseline and 2-, 4-, and 6-weeks post intervention.
Through study completion, up to two years.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Body fat percent
Délai: Through study completion, up to 2 years.
Part 1: The investigators will measure body fat percent using Dual-Energy X-ray Absorptiometry. Part 2: The investigators will measure body fat percent using Dual-Energy X-ray Absorptiometry at baseline and 6-weeks post intervention.
Through study completion, up to 2 years.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ball State University

Les enquêteurs

  • Chercheur principal: Bryant Keirns, PhD, Ball State University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

16 avril 2026

Première soumission répondant aux critères de contrôle qualité

23 avril 2026

Première publication (Réel)

30 avril 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 avril 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB-FY2026-239

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

ClinicalTrials.gov NCBI BioProject NCBI Reference Sequence Open Science Framework (general) Sequence Read Archive (SRA)

Délai de partage IPD

12/31/2027

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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