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Ghrelin and Nutritional Status After a Standardized Meal.

2. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Intervenční

Zápis (Aktuální)

80

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Nerandomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postprandial serum ghrelin concentration
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hemoglobin concentration
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Medical University of Bialystok

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

8. dubna 2025

Primární dokončení (Aktuální)

14. dubna 2026

Dokončení studie (Aktuální)

14. dubna 2026

Termíny zápisu do studia

První předloženo

13. května 2026

První předloženo, které splnilo kritéria kontroly kvality

2. června 2026

První zveřejněno (Aktuální)

4. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • B.SUB.24.112
  • AZN.614.1.2024 (Jiné číslo grantu/financování: Medical University of Bialystok)

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