Gut Hormones and Nutritional Status After a Standardized Meal. (GUT-NUT)
28 maja 2026 zaktualizowane przez: Medical University of Bialystok
Analysis of Differences in Serum Concentrations of Selected Gut Hormones in Patients With Varying Nutritional Status Following Consumption of a Standardized Meal.
This study evaluated differences in serum concentrations of selected gut hormones (GLP-1, GIP, cholecystokinin, and omentin) among individuals with varying nutritional status following a standardized meal.
A total of 80 adults were enrolled and stratified by BMI. Fasting and postprandial hormone 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
Szczegółowy opis
Stage I
Participant recruitment
A total of 80 participants (women and men) aged 40-60 years who voluntarily consent to participate in the study will be enrolled:
Control group (G0): 20 participants (10 women, 10 men) with normal body weight - BMI 18.5-24.9 kg/m² Study group I (G1): 20 participants (10 women, 10 men) with overweight - BMI 25.0-29.9 kg/m² Study group II (G2): 20 participants (10 women, 10 men) with class I obesity - BMI 30.0-34.9 kg/m² Study group III (G3): 20 participants (10 women, 10 men) with class II obesity - BMI 35.0-39.9 kg/m²
Assessment of dietary habits, physical activity, and quality of life
Participants will complete a questionnaire-based survey consisting of the following standardized instruments:
- Questionnaire for the Assessment of Dietary Habits and Opinions on Food and Nutrition (QEB Questionnaire developed by the Committee of Human Nutrition Science, Polish Academy of Sciences);
- International Physical Activity Questionnaire (IPAQ);
- Quality of Life Questionnaire (WHOQOL-BREF);
- The Three-Factor Eating Questionnaire (TFEQ-R18);
- "My Eating Habits: Construction and Psychometric Properties" Questionnaire (N. Ogińska-Bulik, L. Putyński);
- The Hunger-Satiety Scale. The questionnaire survey will enable qualitative assessment of participants' dietary habits, physical activity levels, quality of life, and emotional determinants related to food intake.
Quantitative assessment of dietary intake will be performed using a 24-hour dietary recall collected over three days (two weekdays and one weekend day).
- Nutritional Status Assessment Anthropometric measurements including body height and body weight will be obtained using a calibrated scale with a stadiometer. Waist circumference (cm) will be measured midway between the lower rib margin and the iliac crest, while hip circumference (cm) will be measured at the point of maximum gluteal protuberance. Based on these measurements, the following indices will be calculated: BMI, WHR, WHtR, and RFM.
Body composition analysis will also be performed using dual-energy X-ray absorptiometry (DEXA), which utilizes dual-energy X-ray beams. This technique allows assessment of the whole body and individual body segments by dividing body composition into three main compartments: bone mineral content, lean body mass (excluding bone mineral content), and fat mass.
DEXA is considered a valuable tool for body composition assessment in clinical studies, particularly among individuals with overweight and obesity, as it enables more accurate evaluation of body composition and long-term cardiovascular and oncological risk associated with excess body weight.
The method is safe, rapid, and non-invasive due to the very low radiation dose. Radiation exposure during the examination is approximately 0.001 mSv. The examination is performed in the supine position.
Stage II
- Biochemical analyses: assessment of serum GLP-1, GIP, cholecystokinin, and omentin concentrations in the fasting state and following administration of a standardized meal. Blood samples (10 mL) will be collected for the following laboratory tests: complete blood count (CBC), fasting glucose, fasting insulin, lipid profile (total cholesterol, triglycerides [TG], low-density lipoprotein [LDL], and high-density lipoprotein [HDL]), C-reactive protein (CRP), serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), serum uric acid, serum creatinine. Additionally, fasting blood samples (10 mL) will be collected to determine serum concentrations of GLP-1, GIP, cholecystokinin, and omentin.
- Subsequently, participants will receive a standardized normocarbohydrate meal, and additional blood samples (10 mL each) will be collected at 60, 120, 180, and 240 minutes after meal consumption, individually on the same weekday, in order to assess serum concentrations of GLP-1, GIP, cholecystokinin, and omentin at specified time intervals following standardized meal administration. An isocaloric standardized meal (Nutricia, Poland) will be used in the study, consisting of one and half bottle per participant:
Normocarbohydrate formulation (Nutridrink Standard) Composition of the Standardized Meal - Nutridrink Standard Parameter Per 100 mL Energy 240 kcal Carbohydrates 29.6 g
- of energy 49% Sugars 15.5 g Lactose <0.5 g Fat 9.3 g
- of energy 35% Saturated fatty acids 0.86 g Protein 9.6 g
- of energy 16% Dietary fiber 0 g
Stage III
1. Assessment of Resting Metabolic Rate Indirect calorimetry will be performed to accurately measure resting energy expenditure (REE) and determine the energy substrates utilized by the body (carbohydrates and fats).
The examination involves analysis of exhaled air composition (oxygen and carbon dioxide concentrations) using specialized equipment (Q-NRG+, COSMED). Measurements will be conducted using sterile disposable mouthpieces and an oxygen mask. Indirect calorimetry is completely safe, painless, and non-invasive. The examination will be performed once.
The obtained results will be subjected to statistical analysis using Statistica 13.3 software (StatSoft Inc.).
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
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-
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Bialystok, Polska, 15-089
- Medical University of Bialystok
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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:
- disorders of carbohydrate metabolism,
- endocrine disorders,
- renal and/or hepatic insufficiency,
- gastrointestinal diseases,
- history of gastroenterological or bariatric surgery,
- pharmacological treatment or use of other agents with known or unknown effects on metabolic and hormonal processes,
- other diseases potentially affecting the obtained results,
- pregnancy and lactation.
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)
|
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
|
|
Eksperymentalny: Overweight Group
Participants with overweight (BMI: 25-29.9
kg/m2)
|
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
|
|
Eksperymentalny: Obesity I Group
Participants with class I obesity (BMI: 30-34.9
kg/m2)
|
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
|
|
Eksperymentalny: Obesity II Group
Participants with class II and class III obesity (BMI > 35 kg/m²)
|
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postprandial hormonal response: GLP-1
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Postprandial changes in serum glucagon-like peptide-1 (GLP-1) (pmol/L).
|
24 months (analyzes were performed throughout the study period).
|
|
Postprandial hormonal response: GIP.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Postprandial changes in serum glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).
|
24 months (analyzes were performed throughout the study period).
|
|
Postprandial hormonal response: cholecystokinin.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Postprandial changes in serum cholecystokinin (pg/mL).
|
24 months (analyzes were performed throughout the study period).
|
|
Postprandial hormonal response: omentin.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Postprandial changes in serum omentin (ng/mL).
|
24 months (analyzes were performed throughout the study period).
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Laboratory parameters: hemoglobin.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Complete blood count assessed from fasting venous blood samples, including hemoglobin (g/dl).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: glucose.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Fasting glucose concentration (mg/dL)
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: insulin.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Fasting insulin concentration (µIU/mL)
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: total cholesterol.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Lipid profile parameters: total cholesterol (mg/dL).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: C-reactive protein concentration.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
C-reactive protein concentration (mg/L)
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: ALT.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Alanine aminotransferase activity (U/L).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: AST.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Aspartate aminotransferase activity (U/L).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: creatinine.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Creatinine concentration (mg/dL).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: uric acid.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Uric acid concentration (mg/dL).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: HDL cholesterol.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Lipid profile parameters: HDL cholesterol.
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: TG.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Lipid profile parameters: triglycerides (mg/dL).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: LDL cholesterol.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Lipid profile parameters: LDL cholesterol (mg/dl).
|
24 months (analyzes were performed throughout the study period).
|
|
Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - total fat mass.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Assessment of total fat mass (kg).
|
24 months (analyzes were performed throughout the study period).
|
|
Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - visceral adipose tissue.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Assessment of visceral adipose tissue (cm³).
|
24 months (analyzes were performed throughout the study period).
|
|
Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - lean body mass.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Assessment of lean body mass (kg).
|
24 months (analyzes were performed throughout the study period).
|
|
Physical activity
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Differences in physical activity levels between participants with normal body weight (BMI 18.5-24.9
kg/m²), overweight (BMI 25.0-29.9
kg/m²), obesity I (BMI 30.0-34.9 kg/m²) and obesity II (≥35 kg/m²) assessed using the IPAQ questionnaire.
|
24 months (analyzes were performed throughout the study period).
|
|
Resting Energy Expenditure
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Resting Energy Expenditure: REE was measured using indirect calorimetry (Q-NRG+, COSMED).
|
24 months (analyzes were performed throughout the study period).
|
|
Dietary habits
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Differences in dietary habits between participants with normal body weight (BMI 18.5-24.9
kg/m²), overweight (BMI 25.0-29.9
kg/m²), obesity I (BMI ≥30.0-34.9
kg/m²) and obesity II (BMI ≥35.0 kg/m²), assessed using standardized questionnaires including the QEB, TFEQ-R18, and the hunger-satiety scale.
|
24 months (analyzes were performed throughout the study period).
|
|
Quality of life of people with normal and excessive body weight.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Quality of life assessed using the World Health Organization Quality of Life questionnaire (WHOQOL-BREF).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: hematocrit.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Complete blood count assessed from fasting venous blood samples, including hematocrit (%).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: white blood cell count.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Complete blood count assessed from fasting venous blood samples, including white blood cell count ×10^3/µL.
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: red blood cell count.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Complete blood count assessed from fasting venous blood samples, including red blood cell count ×10^6/µL.
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: platelet count.
Ramy czasowe: 24 months (analyzes were performed throughout the study period).
|
Complete blood count assessed from fasting venous blood samples, including platelet count ×10^3/µL.
|
24 months (analyzes were performed throughout the study period).
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
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
- Shah M, Franklin B, Adams-Huet B, Mitchell J, Bouza B, Dart L, Phillips M. Effect of meal composition on postprandial glucagon-like peptide-1, insulin, glucagon, C-peptide, and glucose responses in overweight/obese subjects. Eur J Nutr. 2017 Apr;56(3):1053-1062. doi: 10.1007/s00394-016-1154-8. Epub 2016 Jan 12.
- Dutta B, Tripathy A, Archana PR, Kamath SU. Unraveling the complexities of diet induced obesity and glucolipid dysfunction in metabolic syndrome. Diabetol Metab Syndr. 2025 Jul 22;17(1):292. doi: 10.1186/s13098-025-01837-y.
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
12 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
28 maja 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
28 maja 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.24.251
- ADN.614.2.2024 (Inny identyfikator: Medical University of Bialystok)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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