Ghrelin and Nutritional Status After a Standardized Meal.
2 июня 2026 г. обновлено: 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.
Обзор исследования
Подробное описание
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
- To compare fasting serum concentrations of ghrelin across nutritional status groups.
- To assess postprandial changes (60, 120, 1880, and 240 minutes) in ghrelin depending on nutritional status.
- 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).
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
-
-
Poland
-
Bialystok, Poland, Польша, 15-089
- Medical University of Bialystok
-
-
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:
- 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
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 consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
|
Экспериментальный: Overweight Group
Participants with overweight (BMI: 25-29.9
kg/m2)
|
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
|
Экспериментальный: Obesity I Group
Participants with class I obesity (BMI: 30-34.9
kg/m2)
|
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
|
Экспериментальный: Obesity II Group
Participants with class II and class III obesity (BMI > 35 kg/m2)
|
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postprandial serum ghrelin concentration
Временное ограничение: 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).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Hemoglobin concentration
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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).
|
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
- Dani C, Giachetti S, Mura M, Tedesco S, Rossi E, Cassioli E, Tarchi L, Micali N, Ricca V, Castellini G. Investigating ghrelin and its isoforms in eating disorders: a network meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Oct 2;142:111489. doi: 10.1016/j.pnpbp.2025.111489. Epub 2025 Sep 10.
- Clarke GS, Page AJ, Eldeghaidy S. The gut-brain axis in appetite, satiety, food intake, and eating behavior: Insights from animal models and human studies. Pharmacol Res Perspect. 2024 Oct;12(5):e70027. doi: 10.1002/prp2.70027.
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
13 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
2 июня 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
2 июня 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.24.112
- AZN.614.1.2024 (Другой номер гранта/финансирования: Medical University of Bialystok)
Планирование данных отдельных участников (IPD)
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Изучает лекарственный продукт, регулируемый FDA США.
Нет
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Нет
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. .