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Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

23. April 2026 aktualisiert von: 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."

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Indiana
      • Muncie, Indiana, Vereinigte Staaten, 47306
        • Rekrutierung
        • Health Professions Building

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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).
Nahrungsergänzungsmittel: Inulin Supplementation
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Nahrungsergänzungsmittel: Maltodextrin (Placebo)
Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).
Sonstiges: 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.
Aktiver Komparator: 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).
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Serum lipopolysaccharide binding protein
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Augmentation Index
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Body fat percent
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ball State University

Ermittler

  • Hauptermittler: Bryant Keirns, PhD, Ball State University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

16. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2026

Zuerst gepostet (Tatsächlich)

30. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. April 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB-FY2026-239

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

12/31/2027

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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