Obesity
Conditions
Keywords
ghrelin, Nutritional status, Obesity, Postpriandal response
Brief summary
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.
Detailed description
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 1. To compare fasting serum concentrations of ghrelin across nutritional status groups. 2. To assess postprandial changes (60, 120, 1880, and 240 minutes) in ghrelin depending on nutritional status. 3. 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).
Interventions
OTHERNutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
Sponsors
Medical University of Bialystok
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Crossover Assignment
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial serum ghrelin concentration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin concentration | 24 months (analyzes were performed throughout the study period). | Hemoglobin level (g/dL) measured in fasting blood samples. |
| White blood cell count | 24 months (analyzes were performed throughout the study period). | WBC count (×10⁹/μL) measured in fasting blood samples. |
| Platelet count | 24 months (analyzes were performed throughout the study period). | Platelet count (×10⁹/μL) measured in fasting blood samples. |
| Fasting glucose concentration | 24 months (analyzes were performed throughout the study period). | Glucose level (mg/dL) measured in fasting blood samples. |
| Fasting insulin concentration | 24 months (analyzes were performed throughout the study period). | Insulin level (µIU/mL) measured in fasting blood samples. |
| Total cholesterol concentration | 24 months (analyzes were performed throughout the study period). | Total cholesterol (mg/dl) measured in fasting blood samples. |
| C-reactive protein concentration | 24 months (analyzes were performed throughout the study period). | CRP level (mg/L) measured in fasting blood samples. |
| Alanine aminotransferase activity | 24 months (analyzes were performed throughout the study period). | ALT level (U/L) measured in serum. |
| Aspartate aminotransferase activity | 24 months (analyzes were performed throughout the study period). | AST level (U/L) measured in serum. |
| Serum uric acid concentration | 24 months (analyzes were performed throughout the study period). | Uric acid level (mg/dL). |
| Serum creatinine concentration | 24 months (analyzes were performed throughout the study period). | Creatinine level (μmol/l). |
| Total fat mass measured by DEXA | 24 months (analyzes were performed throughout the study period). | Total fat mass (kg) assessed using dual-energy X-ray absorptiometry (DEXA). |
| Body fat percentage measured by DEXA | 24 months (analyzes were performed throughout the study period). | Total body fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA). |
| Lean body mass measured by DEXA | 24 months (analyzes were performed throughout the study period). | Lean body mass (kg) assessed using dual-energy X-ray absorptiometry (DEXA). |
| Visceral adipose tissue measured by DEXA | 24 months (analyzes were performed throughout the study period). | Visceral adipose tissue mass (cm³) assessed using dual-energy X-ray absorptiometry (DEXA). |
| Subcutaneous adipose tissue measured by DEXA | 24 months (analyzes were performed throughout the study period). | Subcutaneous adipose tissue mass (cm³) assessed using dual-energy X-ray absorptiometry (DEXA). |
| Android fat percentage measured by DEXA | 24 months (analyzes were performed throughout the study period). | Android fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA). |
| Gynoid fat percentage measured by DEXA | 24 months (analyzes were performed throughout the study period). | Gynoid fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA). |
| Dietary habits score (QEB questionnaire) | 24 months (analyzes were performed throughout the study period). | Score from standardized Questionnaire of Eating Behaviour (QEB). |
| Cognitive restraint, uncontrolled eating, and emotional eating scores (TFEQ-R18) | 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). |
| Hunger and satiety ratings | 24 months (analyzes were performed throughout the study period). | Visual analogue scale or standardized scale (0-10) |
| Physical activity level (IPAQ score) | 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. |
| Quality of life score (WHOQOL-BREF) | 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. |
| Resting energy expenditure measured by indirect calorimetry | 24 months (analyzes were performed throughout the study period). | REE measured in kcal/day using indirect calorimetry (Q-NRG+, COSMED). |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORLucyna Ostrowska, Professor
Department of Dietetics and Clinical Nutrition Medical University of Bialystok
Outcome results
None listed