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Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

23 de abril de 2026 actualizado por: 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."

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Bryant Keirns, PhD
  • Número de teléfono: 765-285-8356
  • Correo electrónico: bryant.keirns@bsu.edu

Ubicaciones de estudio

  • Estados Unidos
    • Indiana
      • Muncie, Indiana, Estados Unidos, 47306
        • Reclutamiento
        • Health Professions Building

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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).
Suplemento dietético: Inulin Supplementation
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Suplemento dietético: Maltodextrin (Placebo)
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Otro: 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.
Comparador activo: 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).
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Serum lipopolysaccharide binding protein
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Augmentation Index
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Body fat percent
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ball State University

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

16 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de abril de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB-FY2026-239

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

12/31/2027

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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