Ghrelin and Nutritional Status After a Standardized Meal.
2 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Descrição detalhada
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).
Tipo de estudo
Intervencional
Inscrição (Real)
80
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Poland
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Bialystok, Poland, Polônia, 15-089
- Medical University of Bialystok
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postprandial serum ghrelin concentration
Prazo: 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).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hemoglobin concentration
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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).
|
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Hunger and satiety ratings
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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).
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Lucyna Ostrowska, Professor, Department of Dietetics and Clinical Nutrition Medical University of Bialystok
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de abril de 2025
Conclusão Primária (Real)
14 de abril de 2026
Conclusão do estudo (Real)
14 de abril de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
13 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B.SUB.24.112
- AZN.614.1.2024 (Número de outro subsídio/financiamento: Medical University of Bialystok)
Plano para dados de participantes individuais (IPD)
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