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Ghrelin and Nutritional Status After a Standardized Meal.

2. Juni 2026 aktualisiert von: Medical University of Bialystok

Analysis of Ghrelin Concentration in the Blood Serum of Patients With Different Nutritional Status Following Consumption of a Standarized Meal.

This study evaluated differences in serum concentrations of ghrelin among individuals with varying nutritional status following a standardized meal.

A total of 80 adults were enrolled and stratified by BMI. Fasting and postprandial ghrelin levels were assessed at multiple time points.

Additionally, dietary habits, physical activity, body composition, and resting energy expenditure were evaluated to explore their association with hormonal responses.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Study Objectives

1. The primary objectives was to evaluate differences in serum concentrations of ghrelin among patients with varying nutritional status following consumption of standarized meal (cross-over design).

Secondary Objectives

  1. To compare fasting serum concentrations of ghrelin across nutritional status groups.
  2. To assess postprandial changes (60, 120, 1880, and 240 minutes) in ghrelin depending on nutritional status.
  3. To compare fasting versus postpradial ghrelin levels. Methods

Study Population: A total of 80 adults (aged 40-60 years) were enrolled and stratified by BMI into the following groups:

Normal weight (BMI 18.5-24.9) Overweight (BMI 25.0-29.9) Obesity class I (BMI 30.0-34.9) Obesity class II and III (BMI ≥ 35.0) Exclusion criteria included: carbohydrate metabolism disorders, endocrine disorders, renal and/or hepatic failure, gastrointestinal diseases, history of gastroenterological and bariatric surgery, pharmacological treatment or other preparations whose effect on metabolic and hormonal changes is documented or unknown, pregnancy, lactation and other diseases that may affect the obtained results.

Dietary Intake, Physical Activity, and Quality of Life:

Validated questionnaires (including QEB, IPAQ, WHOQOL-BREF, AND TFEQ-R18) were used. Dietary intake was assessed using 24-hour dietary recalls collected over 3 days (2 weekdays and 1 weekend day).

Nutritional Status Assessment: Anthropometric measurements (body weight, height, waist and hip circumference) were obtained, and BMI, WHR, WHtR, and RFM were calculated. Body composition was assessed using dual-energy X-ray absorptiometry (DEXA).

Biochemical Measurements: Fasting blood samples were collected to assess: glucose, insulin, lipid profile, CRP, ALT, AST, uric acid, creatinine, and ghrelin. After ingestion of a standarized isocaloric meal (Nutridrink Standard), additional blood samples were collected at 60, 120, 180, and 240 minutes.

Resting energy Expenditure: REE was measured using indirect calorimetry (Q-NRG+, COSMED).

Statistical Analysis: Data were analyzed using Statistica 13.3 (StatSoft).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Polen
    • Poland
      • Bialystok, Poland, Polen, 15-089
        • Medical University of Bialystok

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:

  • women and men aged 40-60

Exclusion Criteria:

  • type I and II diabetes,
  • exacerbated coronary artery disease,
  • endocrine disorders,
  • pregnancy and lactation period,
  • use of hormonal contraception or hormone replacement therapy, steroid therapy, antiretroviral therapy,
  • surgical or pharmacological history obesity treatment,
  • pacemaker

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Normal Body Weight Group
Participants with normal body weight (BMI: 19-24.9 kg/m2)
Sonstiges: Nutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
Experimental: Overweight Group
Participants with overweight (BMI: 25-29.9 kg/m2)
Sonstiges: Nutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
Experimental: Obesity I Group
Participants with class I obesity (BMI: 30-34.9 kg/m2)
Sonstiges: Nutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
Experimental: Obesity II Group
Participants with class II and class III obesity (BMI > 35 kg/m2)
Sonstiges: Nutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postprandial serum ghrelin concentration
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Change in serum ghrelin concentration (pg/mL) over 4 hours following standardized meal intake in participants with different nutritional status. Measurements will be assessed at predefined time points postprandially.
24 months (analyzes were performed throughout the study period).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hemoglobin concentration
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Hemoglobin level (g/dL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
White blood cell count
Zeitfenster: 24 months (analyzes were performed throughout the study period).
WBC count (×10⁹/μL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Platelet count
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Platelet count (×10⁹/μL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Fasting glucose concentration
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Glucose level (mg/dL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Fasting insulin concentration
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Insulin level (µIU/mL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Total cholesterol concentration
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Total cholesterol (mg/dl) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
C-reactive protein concentration
Zeitfenster: 24 months (analyzes were performed throughout the study period).
CRP level (mg/L) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Alanine aminotransferase activity
Zeitfenster: 24 months (analyzes were performed throughout the study period).
ALT level (U/L) measured in serum.
24 months (analyzes were performed throughout the study period).
Aspartate aminotransferase activity
Zeitfenster: 24 months (analyzes were performed throughout the study period).
AST level (U/L) measured in serum.
24 months (analyzes were performed throughout the study period).
Serum uric acid concentration
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Uric acid level (mg/dL).
24 months (analyzes were performed throughout the study period).
Serum creatinine concentration
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Creatinine level (μmol/l).
24 months (analyzes were performed throughout the study period).
Total fat mass measured by DEXA
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Total fat mass (kg) assessed using dual-energy X-ray absorptiometry (DEXA).
24 months (analyzes were performed throughout the study period).
Body fat percentage measured by DEXA
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Total body fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).
24 months (analyzes were performed throughout the study period).
Lean body mass measured by DEXA
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Lean body mass (kg) assessed using dual-energy X-ray absorptiometry (DEXA).
24 months (analyzes were performed throughout the study period).
Visceral adipose tissue measured by DEXA
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Visceral adipose tissue mass (cm³) assessed using dual-energy X-ray absorptiometry (DEXA).
24 months (analyzes were performed throughout the study period).
Subcutaneous adipose tissue measured by DEXA
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Subcutaneous adipose tissue mass (cm³) assessed using dual-energy X-ray absorptiometry (DEXA).
24 months (analyzes were performed throughout the study period).
Android fat percentage measured by DEXA
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Android fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).
24 months (analyzes were performed throughout the study period).
Gynoid fat percentage measured by DEXA
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Gynoid fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).
24 months (analyzes were performed throughout the study period).
Dietary habits score (QEB questionnaire)
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Score from standardized Questionnaire of Eating Behaviour (QEB).
24 months (analyzes were performed throughout the study period).
Cognitive restraint, uncontrolled eating, and emotional eating scores (TFEQ-R18)
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Scores for each subscale of Three-Factor Eating Questionnaire (range 0-100; higher score indicates greater expression of trait).
24 months (analyzes were performed throughout the study period).
Hunger and satiety ratings
Zeitfenster: 24 months (analyzes were performed throughout the study period).
Visual analogue scale or standardized scale (0-10)
24 months (analyzes were performed throughout the study period).
Physical activity level (IPAQ score)
Zeitfenster: 24 months (analyzes were performed throughout the study period).
International Physical Activity Questionnaire (IPAQ) score expressed in MET-minutes/week. Higher values indicate higher physical activity level.
24 months (analyzes were performed throughout the study period).
Quality of life score (WHOQOL-BREF)
Zeitfenster: 24 months (analyzes were performed throughout the study period).
WHOQOL-BREF scores for physical, psychological, social, and environmental domains. Scores range 0-100; higher score indicates better quality of life.
24 months (analyzes were performed throughout the study period).
Resting energy expenditure measured by indirect calorimetry
Zeitfenster: 24 months (analyzes were performed throughout the study period).
REE measured in kcal/day using indirect calorimetry (Q-NRG+, COSMED).
24 months (analyzes were performed throughout the study period).

Mitarbeiter und Ermittler

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

Sponsor

Medical University of Bialystok

Ermittler

  • Hauptermittler: Lucyna Ostrowska, Professor, Department of Dietetics and Clinical Nutrition Medical University of Bialystok

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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)

8. April 2025

Primärer Abschluss (Tatsächlich)

14. April 2026

Studienabschluss (Tatsächlich)

14. April 2026

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juni 2026

Zuerst gepostet (Tatsächlich)

4. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • B.SUB.24.112
  • AZN.614.1.2024 (Andere Zuschuss-/Finanzierungsnummer: Medical University of Bialystok)

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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