Gut Hormones and Nutritional Status After a Standardized Meal. (GUT-NUT)
28 мая 2026 г. обновлено: 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.
Обзор исследования
Подробное описание
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.).
Тип исследования
Интервенционный
Регистрация (Действительный)
80
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
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Bialystok, Польша, 15-089
- Medical University of Bialystok
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Нерандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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).
|
|
Экспериментальный: 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).
|
|
Экспериментальный: 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).
|
|
Экспериментальный: 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).
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postprandial hormonal response: GLP-1
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Laboratory parameters: hemoglobin.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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).
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Lucyna Ostrowska, Professor, Department of Dietetics and Clinical Nutrition Medical University of Bialystok
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
8 апреля 2025 г.
Первичное завершение (Действительный)
14 апреля 2026 г.
Завершение исследования (Действительный)
14 апреля 2026 г.
Даты регистрации исследования
Первый отправленный
12 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
28 мая 2026 г.
Первый опубликованный (Действительный)
4 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
28 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- B.SUB.24.251
- ADN.614.2.2024 (Другой идентификатор: Medical University of Bialystok)
Планирование данных отдельных участников (IPD)
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Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .