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Gut Hormones and Nutritional Status After a Standardized Meal. (GUT-NUT)

28. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Stage I

  1. 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

  2. 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).

  3. 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

  1. 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.
  2. 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 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
      • Bialystok, 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:

  • 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.

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 received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
Experimentální: Overweight Group
Participants with overweight (BMI: 25-29.9 kg/m2)
Jiný: Nutridrink Protein
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
Experimentální: Obesity I Group
Participants with class I obesity (BMI: 30-34.9 kg/m2)
Jiný: Nutridrink Protein
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
Experimentální: Obesity II Group
Participants with class II and class III obesity (BMI > 35 kg/m²)
Jiný: Nutridrink Protein
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postprandial hormonal response: GLP-1
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Laboratory parameters: hemoglobin.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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).

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

12. května 2026

První předloženo, které splnilo kritéria kontroly kvality

28. května 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

28. května 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.24.251
  • ADN.614.2.2024 (Jiný identifikátor: Medical University of Bialystok)

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