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ObesityGUT-NUTNCT07625319

Gut Hormones 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.

Official record
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Trial summary

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. 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

  • disorders of carbohydrate metabolism,
  • endocrine disorders,
  • renal and/or hepatic insufficiency,
  • gastrointestinal diseases,
  • history of gastroenterological or bariatric surgery,
  • pharmacological treatment or use of other agents with known or unknown effects on metabolic and hormonal processes,
  • other diseases potentially affecting the obtained results,
  • pregnancy and lactation.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Medical University of Bialystok

    Bialystok, 15-089

Other trials in Poland

About this study

Official title: Analysis of Differences in Serum Concentrations of Selected Gut Hormones in Patients With Varying Nutritional Status Following Consumption of a Standardized Meal.

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.

Read the detailed description

Stage I

  1. 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
  2. Assessment of dietary habits, physical activity, and quality of life Participants will complete a questionnaire-based survey consisting of the following standardized instruments:
  • Questionnaire for the Assessment of Dietary Habits and Opinions on Food and Nutrition (QEB Questionnaire developed by the Committee of Human Nutrition Science, Polish Academy of Sciences);
  • International Physical Activity Questionnaire (IPAQ);
  • Quality of Life Questionnaire (WHOQOL-BREF);
  • The Three-Factor Eating Questionnaire (TFEQ-R18);
  • "My Eating Habits: Construction and Psychometric Properties" Questionnaire (N. Ogińska-Bulik, L. Putyński);
  • The Hunger-Satiety Scale. The questionnaire survey will enable qualitative assessment of participants' dietary habits, physical activity levels, quality of life, and emotional determinants related to food intake. Quantitative assessment of dietary intake will be performed using a 24-hour dietary recall collected over three days (two weekdays and one weekend day).
  1. Nutritional Status Assessment Anthropometric measurements including body height and body weight will be obtained using a calibrated scale with a stadiometer. Waist circumference (cm) will be measured midway between the lower rib margin and the iliac crest, while hip circumference (cm) will be measured at the point of maximum gluteal protuberance. Based on these measurements, the following indices will be calculated: BMI, WHR, WHtR, and RFM.

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

  1. Biochemical analyses: assessment of serum GLP-1, GIP, cholecystokinin, and omentin concentrations in the fasting state and following administration of a standardized meal. Blood samples (10 mL) will be collected for the following laboratory tests: complete blood count (CBC), fasting glucose, fasting insulin, lipid profile (total cholesterol, triglycerides [TG], low-density lipoprotein [LDL], and high-density lipoprotein [HDL]), C-reactive protein (CRP), serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), serum uric acid, serum creatinine. Additionally, fasting blood samples (10 mL) will be collected to determine serum concentrations of GLP-1, GIP, cholecystokinin, and omentin.
  2. Subsequently, participants will receive a standardized normocarbohydrate meal, and additional blood samples (10 mL each) will be collected at 60, 120, 180, and 240 minutes after meal consumption, individually on the same weekday, in order to assess serum concentrations of GLP-1, GIP, cholecystokinin, and omentin at specified time intervals following standardized meal administration. An isocaloric standardized meal (Nutricia, Poland) will be used in the study, consisting of one and half bottle per participant:

Normocarbohydrate formulation (Nutridrink Standard) Composition of the Standardized Meal - Nutridrink Standard Parameter Per 100 mL Energy 240 kcal Carbohydrates 29.6 g

  • of energy 49% Sugars 15.5 g Lactose <0.5 g Fat 9.3 g
  • of energy 35% Saturated fatty acids 0.86 g Protein 9.6 g
  • of energy 16% Dietary fiber 0 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.).

Conditions
Obesity
Being tested
Nutridrink Protein
Keywords
Gut hormones, GLP-1, GIP, CCK, Omentin, Nutritional status, Obesity, Standardized meal
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 received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).

Study groups in NCT07625319
Study groupRoleWhat they receive
Normal Body Weight GroupExperimentalParticipants with normal body weight (BMI: 19-24.9 kg/m2)
Receives: Other: Nutridrink Protein
Overweight GroupExperimentalParticipants with overweight (BMI: 25-29.9 kg/m2)
Receives: Other: Nutridrink Protein
Obesity I GroupExperimentalParticipants with class I obesity (BMI: 30-34.9 kg/m2)
Receives: Other: Nutridrink Protein
Obesity II GroupExperimentalParticipants 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.

  1. Postprandial hormonal response: GLP-1

    Postprandial changes in serum glucagon-like peptide-1 (GLP-1) (pmol/L).

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

  2. Postprandial hormonal response: GIP.

    Postprandial changes in serum glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).

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

  3. Postprandial hormonal response: cholecystokinin.

    Postprandial changes in serum cholecystokinin (pg/mL).

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

  4. Postprandial hormonal response: omentin.

    Postprandial changes in serum omentin (ng/mL).

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

Secondary outcomes (23)
  1. Laboratory parameters: hemoglobin.

    Complete blood count assessed from fasting venous blood samples, including hemoglobin (g/dl).

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

  2. Laboratory parameters: glucose.

    Laboratory parameters assessed from fasting blood samples. Fasting glucose concentration (mg/dL)

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

  3. Laboratory parameters: insulin.

    Laboratory parameters assessed from fasting blood samples. Fasting insulin concentration (µIU/mL)

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

  4. Laboratory parameters: total cholesterol.

    Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: total cholesterol (mg/dL).

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

  5. Laboratory parameters: C-reactive protein concentration.

    Laboratory parameters assessed from fasting blood samples. C-reactive protein concentration (mg/L)

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

  6. Laboratory parameters: ALT.

    Laboratory parameters assessed from fasting blood samples. Alanine aminotransferase activity (U/L).

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

  7. Laboratory parameters: AST.

    Laboratory parameters assessed from fasting blood samples. Aspartate aminotransferase activity (U/L).

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

  8. Laboratory parameters: creatinine.

    Laboratory parameters assessed from fasting blood samples. Creatinine concentration (mg/dL).

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

  9. Laboratory parameters: uric acid.

    Laboratory parameters assessed from fasting blood samples. Uric acid concentration (mg/dL).

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

  10. Laboratory parameters: HDL cholesterol.

    Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: HDL cholesterol.

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

  11. Laboratory parameters: TG.

    Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: triglycerides (mg/dL).

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

  12. Laboratory parameters: LDL cholesterol.

    Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: LDL cholesterol (mg/dl).

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

  13. Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - total fat mass.

    Assessment of total fat mass (kg).

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

  14. Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - visceral adipose tissue.

    Assessment of visceral adipose tissue (cm³).

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

  15. Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - lean body mass.

    Assessment of lean body mass (kg).

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

  16. 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.

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

  17. Resting Energy Expenditure

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

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

  18. 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.

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

  19. 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).

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

  20. Laboratory parameters: hematocrit.

    Complete blood count assessed from fasting venous blood samples, including hematocrit (%).

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

  21. Laboratory parameters: white blood cell count.

    Complete blood count assessed from fasting venous blood samples, including white blood cell count ×10^3/µL.

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

  22. Laboratory parameters: red blood cell count.

    Complete blood count assessed from fasting venous blood samples, including red blood cell count ×10^6/µL.

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

  23. Laboratory parameters: platelet count.

    Complete blood count assessed from fasting venous blood samples, including platelet count ×10^3/µL.

    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.

  1. First posted4 Jun 2026
  2. Study start8 Apr 2025
  3. Primary completion14 Apr 2026
  4. Study completion14 Apr 2026

Resources

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
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07625319
Sponsor's protocol ID
B.SUB.24.251
Other IDs
ADN.614.2.2024
Acronym
GUT-NUT
Status last verified
May 2026
First submitted
12 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

  • Shah M, Franklin B, Adams-Huet B, Mitchell J, Bouza B, Dart L, Phillips M. Effect of meal composition on postprandial glucagon-like peptide-1, insulin, glucagon, C-peptide, and glucose responses in overweight/obese subjects. Eur J Nutr. 2017 Apr;56(3):1053-1062. doi: 10.1007/s00394-016-1154-8. Epub 2016 Jan 12.

    PubMed 26759261
  • Dutta B, Tripathy A, Archana PR, Kamath SU. Unraveling the complexities of diet induced obesity and glucolipid dysfunction in metabolic syndrome. Diabetol Metab Syndr. 2025 Jul 22;17(1):292. doi: 10.1186/s13098-025-01837-y.

    PubMed 40696355

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 8 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 hormonal response: GLP-1 (time frame: 24 months (analyzes were performed throughout the study period).). The study lists 4 primary outcomes in all. 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 NCT07625319, 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.

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