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Ghrelin and Nutritional Status After a Standardized Meal.

2 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Postprandial serum ghrelin concentration
Ramy czasowe: 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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Hemoglobin concentration
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Medical University of Bialystok

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

8 kwietnia 2025

Zakończenie podstawowe (Rzeczywisty)

14 kwietnia 2026

Ukończenie studiów (Rzeczywisty)

14 kwietnia 2026

Daty rejestracji na studia

Pierwszy przesłany

13 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • B.SUB.24.112
  • AZN.614.1.2024 (Inny numer grantu/finansowania: Medical University of Bialystok)

Plan dla danych uczestnika indywidualnego (IPD)

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NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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