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| ID | Type | Description | Link |
|---|---|---|---|
| AZN.614.1.2024 | Other Grant/Funding Number | Medical University of Bialystok |
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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.
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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Body Weight Group | Experimental | Participants with normal body weight (BMI: 19-24.9 kg/m2) |
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| Overweight Group | Experimental | Participants with overweight (BMI: 25-29.9 kg/m2) |
|
| Obesity I Group | Experimental | Participants with class I obesity (BMI: 30-34.9 kg/m2) |
|
| Obesity II Group | Experimental | Participants with class II and class III obesity (BMI > 35 kg/m2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutridrink Protein | Other | Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Postprandial serum ghrelin concentration | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin concentration | Hemoglobin level (g/dL) measured in fasting blood samples. | 24 months (analyzes were performed throughout the study period). |
| White blood cell count | WBC count (×10⁹/μL) measured in fasting blood samples. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucyna Ostrowska, Professor | Department of Dietetics and Clinical Nutrition Medical University of Bialystok | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Bialystok | Bialystok | Poland | 15-089 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40939947 | Background | 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. | |
| 39417406 | Background |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Crossover Assignment
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| 24 months (analyzes were performed throughout the study period). |
| Platelet count | Platelet count (×10⁹/μL) measured in fasting blood samples. | 24 months (analyzes were performed throughout the study period). |
| Fasting glucose concentration | Glucose level (mg/dL) measured in fasting blood samples. | 24 months (analyzes were performed throughout the study period). |
| Fasting insulin concentration | Insulin level (µIU/mL) measured in fasting blood samples. | 24 months (analyzes were performed throughout the study period). |
| Total cholesterol concentration | Total cholesterol (mg/dl) measured in fasting blood samples. | 24 months (analyzes were performed throughout the study period). |
| C-reactive protein concentration | CRP level (mg/L) measured in fasting blood samples. | 24 months (analyzes were performed throughout the study period). |
| Alanine aminotransferase activity | ALT level (U/L) measured in serum. | 24 months (analyzes were performed throughout the study period). |
| Aspartate aminotransferase activity | AST level (U/L) measured in serum. | 24 months (analyzes were performed throughout the study period). |
| Serum uric acid concentration | Uric acid level (mg/dL). | 24 months (analyzes were performed throughout the study period). |
| Serum creatinine concentration | Creatinine level (μmol/l). | 24 months (analyzes were performed throughout the study period). |
| Total fat mass measured by DEXA | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | Visual analogue scale or standardized scale (0-10) | 24 months (analyzes were performed throughout the study period). |
| Physical activity level (IPAQ score) | 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) | 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 | REE measured in kcal/day using indirect calorimetry (Q-NRG+, COSMED). | 24 months (analyzes were performed throughout the study period). |
| 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |