Gut Hormones and Nutritional Status After a Standardized Meal. (GUT-NUT)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Nutridrink Protein

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).

3. 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.).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• women and men aged 40-60

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal Body Weight Group; Participants with normal body weight (BMI: 19-24.9 kg/m2)	Other: Nutridrink Protein; Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
Experimental: Overweight Group; Participants with overweight (BMI: 25-29.9 kg/m2)	Other: Nutridrink Protein; Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
Experimental: Obesity I Group; Participants with class I obesity (BMI: 30-34.9 kg/m2)	Other: Nutridrink Protein; Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
Experimental: Obesity II Group; Participants with class II and class III obesity (BMI > 35 kg/m²)	Other: Nutridrink Protein; Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial hormonal response: GLP-1	Postprandial changes in serum glucagon-like peptide-1 (GLP-1) (pmol/L).	24 months (analyzes were performed throughout the study period).
Postprandial hormonal response: GIP.	Postprandial changes in serum glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).	24 months (analyzes were performed throughout the study period).
Postprandial hormonal response: cholecystokinin.	Postprandial changes in serum cholecystokinin (pg/mL).	24 months (analyzes were performed throughout the study period).
Postprandial hormonal response: omentin.	Postprandial changes in serum omentin (ng/mL).	24 months (analyzes were performed throughout the study period).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory parameters: hemoglobin.	Complete blood count assessed from fasting venous blood samples, including hemoglobin (g/dl).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: glucose.	Laboratory parameters assessed from fasting blood samples. Fasting glucose concentration (mg/dL)	24 months (analyzes were performed throughout the study period).
Laboratory parameters: insulin.	Laboratory parameters assessed from fasting blood samples. Fasting insulin concentration (µIU/mL)	24 months (analyzes were performed throughout the study period).
Laboratory parameters: total cholesterol.	Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: total cholesterol (mg/dL).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: C-reactive protein concentration.	Laboratory parameters assessed from fasting blood samples. C-reactive protein concentration (mg/L)	24 months (analyzes were performed throughout the study period).
Laboratory parameters: ALT.	Laboratory parameters assessed from fasting blood samples. Alanine aminotransferase activity (U/L).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: AST.	Laboratory parameters assessed from fasting blood samples. Aspartate aminotransferase activity (U/L).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: creatinine.	Laboratory parameters assessed from fasting blood samples. Creatinine concentration (mg/dL).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: uric acid.	Laboratory parameters assessed from fasting blood samples. Uric acid concentration (mg/dL).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: HDL cholesterol.	Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: HDL cholesterol.	24 months (analyzes were performed throughout the study period).
Laboratory parameters: TG.	Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: triglycerides (mg/dL).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: LDL cholesterol.	Laboratory parameters assessed from fasting blood samples. Lipid profile parameters: LDL cholesterol (mg/dl).	24 months (analyzes were performed throughout the study period).
Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - total fat mass.	Assessment of total fat mass (kg).	24 months (analyzes were performed throughout the study period).
Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - visceral adipose tissue.	Assessment of visceral adipose tissue (cm³).	24 months (analyzes were performed throughout the study period).
Body composition parameters assessed by dual-energy X-ray absorptiometry (DXA) - lean body mass.	Assessment of lean body mass (kg).	24 months (analyzes were performed throughout the study period).
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.	24 months (analyzes were performed throughout the study period).
Resting Energy Expenditure	Resting Energy Expenditure: REE was measured using indirect calorimetry (Q-NRG+, COSMED).	24 months (analyzes were performed throughout the study period).
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.	24 months (analyzes were performed throughout the study period).
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).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: hematocrit.	Complete blood count assessed from fasting venous blood samples, including hematocrit (%).	24 months (analyzes were performed throughout the study period).
Laboratory parameters: white blood cell count.	Complete blood count assessed from fasting venous blood samples, including white blood cell count ×10^3/µL.	24 months (analyzes were performed throughout the study period).
Laboratory parameters: red blood cell count.	Complete blood count assessed from fasting venous blood samples, including red blood cell count ×10^6/µL.	24 months (analyzes were performed throughout the study period).
Laboratory parameters: platelet count.	Complete blood count assessed from fasting venous blood samples, including platelet count ×10^3/µL.	24 months (analyzes were performed throughout the study period).

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Investigators: Principal Investigator: Lucyna Ostrowska, Professor, Department of Dietetics and Clinical Nutrition Medical University of Bialystok

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Actual): April 14, 2026
• Study Completion (Actual): April 14, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; GLP-1; Nutritional status; CCK; GIP; Gut hormones; Omentin; Standardized meal
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: B.SUB.24.251; ADN.614.2.2024 (Other Identifier: 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