Ghrelin and Nutritional Status After a Standardized Meal.

June 2, 2026 updated by: Medical University of Bialystok

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Poland
      • Bialystok, Poland, Poland, 15-089
        • Medical University of Bialystok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal Body Weight Group
Participants with normal body weight (BMI: 19-24.9 kg/m2)
Other: Nutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
Experimental: Overweight Group
Participants with overweight (BMI: 25-29.9 kg/m2)
Other: Nutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
Experimental: Obesity I Group
Participants with class I obesity (BMI: 30-34.9 kg/m2)
Other: Nutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
Experimental: Obesity II Group
Participants with class II and class III obesity (BMI > 35 kg/m2)
Other: Nutridrink Protein
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months (analyzes were performed throughout the study period).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemoglobin concentration
Time Frame: 24 months (analyzes were performed throughout the study period).
Hemoglobin level (g/dL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
White blood cell count
Time Frame: 24 months (analyzes were performed throughout the study period).
WBC count (×10⁹/μL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Platelet count
Time Frame: 24 months (analyzes were performed throughout the study period).
Platelet count (×10⁹/μL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Fasting glucose concentration
Time Frame: 24 months (analyzes were performed throughout the study period).
Glucose level (mg/dL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Fasting insulin concentration
Time Frame: 24 months (analyzes were performed throughout the study period).
Insulin level (µIU/mL) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Total cholesterol concentration
Time Frame: 24 months (analyzes were performed throughout the study period).
Total cholesterol (mg/dl) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
C-reactive protein concentration
Time Frame: 24 months (analyzes were performed throughout the study period).
CRP level (mg/L) measured in fasting blood samples.
24 months (analyzes were performed throughout the study period).
Alanine aminotransferase activity
Time Frame: 24 months (analyzes were performed throughout the study period).
ALT level (U/L) measured in serum.
24 months (analyzes were performed throughout the study period).
Aspartate aminotransferase activity
Time Frame: 24 months (analyzes were performed throughout the study period).
AST level (U/L) measured in serum.
24 months (analyzes were performed throughout the study period).
Serum uric acid concentration
Time Frame: 24 months (analyzes were performed throughout the study period).
Uric acid level (mg/dL).
24 months (analyzes were performed throughout the study period).
Serum creatinine concentration
Time Frame: 24 months (analyzes were performed throughout the study period).
Creatinine level (μmol/l).
24 months (analyzes were performed throughout the study period).
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).
24 months (analyzes were performed throughout the study period).
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).
24 months (analyzes were performed throughout the study period).
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).
24 months (analyzes were performed throughout the study period).
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).
24 months (analyzes were performed throughout the study period).
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).
24 months (analyzes were performed throughout the study period).
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).
24 months (analyzes were performed throughout the study period).
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).
24 months (analyzes were performed throughout the study period).
Dietary habits score (QEB questionnaire)
Time Frame: 24 months (analyzes were performed throughout the study period).
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)
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).
24 months (analyzes were performed throughout the study period).
Hunger and satiety ratings
Time Frame: 24 months (analyzes were performed throughout the study period).
Visual analogue scale or standardized scale (0-10)
24 months (analyzes were performed throughout the study period).
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.
24 months (analyzes were performed throughout the study period).
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 months (analyzes were performed throughout the study period).
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).
24 months (analyzes were performed throughout the study period).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Bialystok

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lucyna Ostrowska, Professor, Department of Dietetics and Clinical Nutrition Medical University of Bialystok

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B.SUB.24.112
  • AZN.614.1.2024 (Other Grant/Funding Number: Medical University of Bialystok)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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