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| ID | Type | Description | Link |
|---|---|---|---|
| ADN.614.2.2024 | Other Identifier | Medical University of Bialystok |
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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.
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:
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
Normocarbohydrate formulation (Nutridrink Standard) Composition of the Standardized Meal - Nutridrink Standard Parameter Per 100 mL Energy 240 kcal Carbohydrates 29.6 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.).
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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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutridrink Protein | Other | Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial hormonal response: GLP-1 | 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. | Postprandial changes in serum glucose-dependent insulinotropic polypeptide (GIP) (pg/mL). | 24 months (analyzes were performed throughout the study period). |
| Postprandial hormonal response: cholecystokinin. | Postprandial changes in serum cholecystokinin (pg/mL). | 24 months (analyzes were performed throughout the study period). |
| Postprandial hormonal response: omentin. | Postprandial changes in serum omentin (ng/mL). | 24 months (analyzes were performed throughout the study period). |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory parameters: hemoglobin. | 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. |
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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 | 15-089 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26759261 | Background | 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. | |
| 40696355 | 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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Laboratory parameters assessed from fasting blood samples. Fasting glucose concentration (mg/dL)
| 24 months (analyzes were performed throughout the study period). |
| Laboratory parameters: insulin. | 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. | 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. | 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. | Laboratory parameters assessed from fasting blood samples. Alanine aminotransferase activity (U/L). | 24 months (analyzes were performed throughout the study period). |
| Laboratory parameters: AST. | Laboratory parameters assessed from fasting blood samples. Aspartate aminotransferase activity (U/L). | 24 months (analyzes were performed throughout the study period). |
| Laboratory parameters: creatinine. | Laboratory parameters assessed from fasting blood samples. Creatinine concentration (mg/dL). | 24 months (analyzes were performed throughout the study period). |
| Laboratory parameters: uric acid. | 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. | Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: HDL cholesterol. | 24 months (analyzes were performed throughout the study period). |
| Laboratory parameters: TG. | 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. | 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. | 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. | 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. | Assessment of lean body mass (kg). | 24 months (analyzes were performed throughout the study period). |
| Physical activity | 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 | Resting Energy Expenditure: REE was measured using indirect calorimetry (Q-NRG+, COSMED). | 24 months (analyzes were performed throughout the study period). |
| Dietary habits | 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. | 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. | 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. | 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. | 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. | Complete blood count assessed from fasting venous blood samples, including platelet count ×10^3/µL. | 24 months (analyzes were performed throughout the study period). |
| 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |