Ghrelin and Nutritional Status After a Standardized Meal.
2 juni 2026 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Poland
-
Bialystok, Poland, Polen, 15-089
- Medical University of Bialystok
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postprandial serum ghrelin concentration
Tidsram: 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hemoglobin concentration
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Lucyna Ostrowska, Professor, Department of Dietetics and Clinical Nutrition Medical University of Bialystok
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 april 2025
Primärt slutförande (Faktisk)
14 april 2026
Avslutad studie (Faktisk)
14 april 2026
Studieregistreringsdatum
Först inskickad
13 maj 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B.SUB.24.112
- AZN.614.1.2024 (Annat bidrag/finansieringsnummer: Medical University of Bialystok)
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