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Completed

NCT Number: NCT07627802

Ghrelin and Nutritional Status After a Standardized 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Bialystok

Bialystok, Poland, 15-089

About this study

Study Objectives

  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutridrink Protein

Other

Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.

Primary outcomes

  1. Postprandial serum ghrelin concentration

    Time frame: 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 outcomes

  1. Hemoglobin concentration

    Time frame: 24 months (analyzes were performed throughout the study period).

    Hemoglobin level (g/dL) measured in fasting blood samples.

  2. White blood cell count

    Time frame: 24 months (analyzes were performed throughout the study period).

    WBC count (×10⁹/μL) measured in fasting blood samples.

  3. Platelet count

    Time frame: 24 months (analyzes were performed throughout the study period).

    Platelet count (×10⁹/μL) measured in fasting blood samples.

  4. Fasting glucose concentration

    Time frame: 24 months (analyzes were performed throughout the study period).

    Glucose level (mg/dL) measured in fasting blood samples.

  5. Fasting insulin concentration

    Time frame: 24 months (analyzes were performed throughout the study period).

    Insulin level (µIU/mL) measured in fasting blood samples.

  6. Total cholesterol concentration

    Time frame: 24 months (analyzes were performed throughout the study period).

    Total cholesterol (mg/dl) measured in fasting blood samples.

  7. C-reactive protein concentration

    Time frame: 24 months (analyzes were performed throughout the study period).

    CRP level (mg/L) measured in fasting blood samples.

  8. Alanine aminotransferase activity

    Time frame: 24 months (analyzes were performed throughout the study period).

    ALT level (U/L) measured in serum.

  9. Aspartate aminotransferase activity

    Time frame: 24 months (analyzes were performed throughout the study period).

    AST level (U/L) measured in serum.

  10. Serum uric acid concentration

    Time frame: 24 months (analyzes were performed throughout the study period).

    Uric acid level (mg/dL).

  11. Serum creatinine concentration

    Time frame: 24 months (analyzes were performed throughout the study period).

    Creatinine level (μmol/l).

  12. Total fat mass measured by DEXA

    Time frame: 24 months (analyzes were performed throughout the study period).

    Total fat mass (kg) assessed using dual-energy X-ray absorptiometry (DEXA).

  13. Body fat percentage measured by DEXA

    Time frame: 24 months (analyzes were performed throughout the study period).

    Total body fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).

  14. Lean body mass measured by DEXA

    Time frame: 24 months (analyzes were performed throughout the study period).

    Lean body mass (kg) assessed using dual-energy X-ray absorptiometry (DEXA).

  15. Visceral adipose tissue measured by DEXA

    Time frame: 24 months (analyzes were performed throughout the study period).

    Visceral adipose tissue mass (cm³) assessed using dual-energy X-ray absorptiometry (DEXA).

  16. Subcutaneous adipose tissue measured by DEXA

    Time frame: 24 months (analyzes were performed throughout the study period).

    Subcutaneous adipose tissue mass (cm³) assessed using dual-energy X-ray absorptiometry (DEXA).

  17. Android fat percentage measured by DEXA

    Time frame: 24 months (analyzes were performed throughout the study period).

    Android fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).

  18. Gynoid fat percentage measured by DEXA

    Time frame: 24 months (analyzes were performed throughout the study period).

    Gynoid fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).

  19. Dietary habits score (QEB questionnaire)

    Time frame: 24 months (analyzes were performed throughout the study period).

    Score from standardized Questionnaire of Eating Behaviour (QEB).

  20. Cognitive restraint, uncontrolled eating, and emotional eating scores (TFEQ-R18)

    Time frame: 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).

  21. Hunger and satiety ratings

    Time frame: 24 months (analyzes were performed throughout the study period).

    Visual analogue scale or standardized scale (0-10)

  22. Physical activity level (IPAQ score)

    Time frame: 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.

  23. Quality of life score (WHOQOL-BREF)

    Time frame: 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. Resting energy expenditure measured by indirect calorimetry

    Time frame: 24 months (analyzes were performed throughout the study period).

    REE measured in kcal/day using indirect calorimetry (Q-NRG+, COSMED).

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

Analysis of Ghrelin Concentration in the Blood Serum of Patients With Different Nutritional Status Following Consumption of a Standarized Meal.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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