ObesityNCT07627802

Ghrelin and Nutritional Status After a Standardized Meal.

A study testing Nutridrink Protein in people with Obesity, run by Medical University of Bialystok at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 40 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Nutridrink Protein
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 sitePoland
Study dates: 8 Apr 2025to 14 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

women and men aged 40-60

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

Medical University of Bialystok
Bialystok, Poland, 15-089

Other trials in Poland

About this study

Official title: 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.

Read the detailed description

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).

Conditions: Obesity
Being tested: Nutridrink Protein
Keywords: ghrelin, Nutritional status, Obesity, Postpriandal response
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07627802
Study group	Role	What they receive
Normal Body Weight Group	Experimental	Participants with normal body weight (BMI: 19-24.9 kg/m2) Receives: Other: Nutridrink Protein
Overweight Group	Experimental	Participants with overweight (BMI: 25-29.9 kg/m2) Receives: Other: Nutridrink Protein
Obesity I Group	Experimental	Participants with class I obesity (BMI: 30-34.9 kg/m2) Receives: Other: Nutridrink Protein
Obesity II Group	Experimental	Participants with class II and class III obesity (BMI > 35 kg/m2) Receives: Other: Nutridrink Protein

What is being measured

The primary outcome is the main question the study is designed to answer.

Postprandial serum ghrelin concentration
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.
Measured: 24 months (analyzes were performed throughout the study period).

Secondary outcomes (24)

Hemoglobin concentration
Hemoglobin level (g/dL) measured in fasting blood samples.
Measured: 24 months (analyzes were performed throughout the study period).
White blood cell count
WBC count (×10⁹/μL) measured in fasting blood samples.
Measured: 24 months (analyzes were performed throughout the study period).
Platelet count
Platelet count (×10⁹/μL) measured in fasting blood samples.
Measured: 24 months (analyzes were performed throughout the study period).
Fasting glucose concentration
Glucose level (mg/dL) measured in fasting blood samples.
Measured: 24 months (analyzes were performed throughout the study period).
Fasting insulin concentration
Insulin level (µIU/mL) measured in fasting blood samples.
Measured: 24 months (analyzes were performed throughout the study period).
Total cholesterol concentration
Total cholesterol (mg/dl) measured in fasting blood samples.
Measured: 24 months (analyzes were performed throughout the study period).
C-reactive protein concentration
CRP level (mg/L) measured in fasting blood samples.
Measured: 24 months (analyzes were performed throughout the study period).
Alanine aminotransferase activity
ALT level (U/L) measured in serum.
Measured: 24 months (analyzes were performed throughout the study period).
Aspartate aminotransferase activity
AST level (U/L) measured in serum.
Measured: 24 months (analyzes were performed throughout the study period).
Serum uric acid concentration
Uric acid level (mg/dL).
Measured: 24 months (analyzes were performed throughout the study period).
Serum creatinine concentration
Creatinine level (μmol/l).
Measured: 24 months (analyzes were performed throughout the study period).
Total fat mass measured by DEXA
Total fat mass (kg) assessed using dual-energy X-ray absorptiometry (DEXA).
Measured: 24 months (analyzes were performed throughout the study period).
Body fat percentage measured by DEXA
Total body fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).
Measured: 24 months (analyzes were performed throughout the study period).
Lean body mass measured by DEXA
Lean body mass (kg) assessed using dual-energy X-ray absorptiometry (DEXA).
Measured: 24 months (analyzes were performed throughout the study period).
Visceral adipose tissue measured by DEXA
Visceral adipose tissue mass (cm³) assessed using dual-energy X-ray absorptiometry (DEXA).
Measured: 24 months (analyzes were performed throughout the study period).
Subcutaneous adipose tissue measured by DEXA
Subcutaneous adipose tissue mass (cm³) assessed using dual-energy X-ray absorptiometry (DEXA).
Measured: 24 months (analyzes were performed throughout the study period).
Android fat percentage measured by DEXA
Android fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).
Measured: 24 months (analyzes were performed throughout the study period).
Gynoid fat percentage measured by DEXA
Gynoid fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).
Measured: 24 months (analyzes were performed throughout the study period).
Dietary habits score (QEB questionnaire)
Score from standardized Questionnaire of Eating Behaviour (QEB).
Measured: 24 months (analyzes were performed throughout the study period).
Cognitive restraint, uncontrolled eating, and emotional eating scores (TFEQ-R18)
Scores for each subscale of Three-Factor Eating Questionnaire (range 0-100; higher score indicates greater expression of trait).
Measured: 24 months (analyzes were performed throughout the study period).
Hunger and satiety ratings
Visual analogue scale or standardized scale (0-10)
Measured: 24 months (analyzes were performed throughout the study period).
Physical activity level (IPAQ score)
International Physical Activity Questionnaire (IPAQ) score expressed in MET-minutes/week. Higher values indicate higher physical activity level.
Measured: 24 months (analyzes were performed throughout the study period).
Quality of life score (WHOQOL-BREF)
WHOQOL-BREF scores for physical, psychological, social, and environmental domains. Scores range 0-100; higher score indicates better quality of life.
Measured: 24 months (analyzes were performed throughout the study period).
Resting energy expenditure measured by indirect calorimetry
REE measured in kcal/day using indirect calorimetry (Q-NRG+, COSMED).
Measured: 24 months (analyzes were performed throughout the study period).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202514 Apr 2026

First posted4 Jun 2026
Study start8 Apr 2025
Primary completion14 Apr 2026
Study completion14 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Model description: Crossover Assignment
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07627802
Sponsor's protocol ID: B.SUB.24.112
Other IDs: AZN.614.1.2024
Status last verified: May 2026
First submitted: 13 May 2026
Last updated: 4 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Dani C, Giachetti S, Mura M, Tedesco S, Rossi E, Cassioli E, Tarchi L, Micali N, Ricca V, Castellini G. Investigating ghrelin and its isoforms in eating disorders: a network meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Oct 2;142:111489. doi: 10.1016/j.pnpbp.2025.111489. Epub 2025 Sep 10.
PubMed 40939947
Clarke GS, Page AJ, Eldeghaidy S. The gut-brain axis in appetite, satiety, food intake, and eating behavior: Insights from animal models and human studies. Pharmacol Res Perspect. 2024 Oct;12(5):e70027. doi: 10.1002/prp2.70027.
PubMed 39417406

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysis of Ghrelin Concentration in the Blood Serum of Patients With Different Nutritional Status Following Consumption of a Standarized Meal.
ClinicalTrials.gov ID: NCT07627802
Acronym / sponsor ID: B.SUB.24.112
Conditions: Obesity
Keywords: ghrelin, Nutritional status, Obesity, Postpriandal response
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Medical University of BialystokUniversity, hospital or other
Study start: 8 Apr 2025 (actual)
Primary completion: 14 Apr 2026 (actual)
Study completion: 14 Apr 2026 (actual)
First posted: 4 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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:

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).

Resting energy Expenditure: REE was measured using indirect calorimetry (Q-NRG+, COSMED).

Statistical Analysis: Data were analyzed using Statistica 13.3 (StatSoft).

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: Crossover Assignment

Arm	Type	Receives
Normal Body Weight Group	Experimental	Other: Nutridrink ProteinParticipants with normal body weight (BMI: 19-24.9 kg/m2)
Overweight Group	Experimental	Other: Nutridrink ProteinParticipants with overweight (BMI: 25-29.9 kg/m2)
Obesity I Group	Experimental	Other: Nutridrink ProteinParticipants with class I obesity (BMI: 30-34.9 kg/m2)
Obesity II Group	Experimental	Other: Nutridrink ProteinParticipants with class II and class III obesity (BMI > 35 kg/m2)

Who may qualify

Ages: 40 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

women and men aged 40-60

Key exclusion criteria (7 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nutridrink ProteinParticipants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.	Other	Normal Body Weight Group, Obesity I Group, Obesity II Group, Overweight Group

Primary outcome

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 secondary outcomes

Hemoglobin concentration
Time frame: 24 months (analyzes were performed throughout the study period).
White blood cell count
Time frame: 24 months (analyzes were performed throughout the study period).
Platelet count
Time frame: 24 months (analyzes were performed throughout the study period).
Fasting glucose concentration
Time frame: 24 months (analyzes were performed throughout the study period).
Fasting insulin concentration
Time frame: 24 months (analyzes were performed throughout the study period).
Total cholesterol concentration
Time frame: 24 months (analyzes were performed throughout the study period).
C-reactive protein concentration
Time frame: 24 months (analyzes were performed throughout the study period).
Alanine aminotransferase activity
Time frame: 24 months (analyzes were performed throughout the study period).
Aspartate aminotransferase activity
Time frame: 24 months (analyzes were performed throughout the study period).
Serum uric acid concentration
Time frame: 24 months (analyzes were performed throughout the study period).
Serum creatinine concentration
Time frame: 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).
Body fat percentage measured by DEXA
Time frame: 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).
Visceral adipose tissue measured by DEXA
Time frame: 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).
Android fat percentage measured by DEXA
Time frame: 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).
Dietary habits score (QEB questionnaire)
Time frame: 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).
Hunger and satiety ratings
Time frame: 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).
Quality of life score (WHOQOL-BREF)
Time frame: 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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Background: PubMed 40939947Dani C, Giachetti S, Mura M, Tedesco S, Rossi E, Cassioli E, Tarchi L, Micali N, Ricca V, Castellini G. Investigating ghrelin and its isoforms in eating disorders: a network meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Oct 2;142:111489. doi: 10.1016/j.pnpbp.2025.111489. Epub 2025 Sep 10.
Background: PubMed 39417406Clarke GS, Page AJ, Eldeghaidy S. The gut-brain axis in appetite, satiety, food intake, and eating behavior: Insights from animal models and human studies. Pharmacol Res Perspect. 2024 Oct;12(5):e70027. doi: 10.1002/prp2.70027.
Individual participant dataSharing planned: Undecided

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Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
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Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lucyna Ostrowska, Professor principal investigator

Department of Dietetics and Clinical Nutrition Medical University of Bialystok

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nutridrink Protein in people with Obesity, run by Medical University of Bialystok at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial serum ghrelin concentration (time frame: 24 months (analyzes were performed throughout the study period).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07627802, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.