An interventional study of Nutridrink Protein in Obesity, sponsored by Medical University of Bialystok. Completed at 1 site in Poland. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Medical University of Bialystok · Not applicable, Interventional, and Other
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).
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.).
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 80 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Medical University of Bialystok is the lead sponsor of 68 studies on the registry; 17 are open to participants now.
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Exclusion criteria:
Participants with normal body weight (BMI: 19-24.9 kg/m2)
Other: Nutridrink Protein
Participants with overweight (BMI: 25-29.9 kg/m2)
Other: Nutridrink Protein
Participants with class I obesity (BMI: 30-34.9 kg/m2)
Other: Nutridrink Protein
Participants with class II and class III obesity (BMI \> 35 kg/m²)
Other: Nutridrink Protein
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
Postprandial hormonal response: GLP-1
Postprandial changes in serum glucagon-like peptide-1 (GLP-1) (pmol/L).
Time frame: 24 months (analyzes were performed throughout the study period).
Postprandial hormonal response: GIP.
Postprandial changes in serum glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).
Time frame: 24 months (analyzes were performed throughout the study period).
Postprandial hormonal response: cholecystokinin.
Postprandial changes in serum cholecystokinin (pg/mL).
Time frame: 24 months (analyzes were performed throughout the study period).
Postprandial hormonal response: omentin.
Postprandial changes in serum omentin (ng/mL).
Time frame: 24 months (analyzes were performed throughout the study period).
Laboratory parameters: hemoglobin.
Complete blood count assessed from fasting venous blood samples, including hemoglobin (g/dl).
Time frame: 24 months (analyzes were performed throughout the study period).
Laboratory parameters: glucose.
Laboratory parameters assessed from fasting blood samples. Fasting glucose concentration (mg/dL)
Time frame: 24 months (analyzes were performed throughout the study period).
Laboratory parameters: insulin.
Laboratory parameters assessed from fasting blood samples. Fasting insulin concentration (µIU/mL)
Time frame: 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).
Time frame: 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)
Time frame: 24 months (analyzes were performed throughout the study period).
Laboratory parameters: ALT.
Laboratory parameters assessed from fasting blood samples. Alanine aminotransferase activity (U/L).
Time frame: 24 months (analyzes were performed throughout the study period).
Laboratory parameters: AST.
Laboratory parameters assessed from fasting blood samples. Aspartate aminotransferase activity (U/L).
Time frame: 24 months (analyzes were performed throughout the study period).
Laboratory parameters: creatinine.
Laboratory parameters assessed from fasting blood samples. Creatinine concentration (mg/dL).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 24 months (analyzes were performed throughout the study period).
Resting Energy Expenditure
Resting Energy Expenditure: REE was measured using indirect calorimetry (Q-NRG+, COSMED).
Time frame: 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.
Time frame: 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).
Time frame: 24 months (analyzes were performed throughout the study period).
Laboratory parameters: hematocrit.
Complete blood count assessed from fasting venous blood samples, including hematocrit (%).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months (analyzes were performed throughout the study period).
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Medical University of Bialystok