Gut Hormones and Nutritional Status After a Standardized Meal. (GUT-NUT)
2026年5月28日 更新者：Medical University of Bialystok
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.
調査の概要
詳細な説明
Stage I
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
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).
- 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
- 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.
- 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.).
研究の種類
介入
入学 (実際)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Bialystok、ポーランド、15-089
- Medical University of Bialystok
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Normal Body Weight Group
Participants with normal body weight (BMI: 19-24.9
kg/m2)
|
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
|
|
実験的：Overweight Group
Participants with overweight (BMI: 25-29.9
kg/m2)
|
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
|
|
実験的：Obesity I Group
Participants with class I obesity (BMI: 30-34.9
kg/m2)
|
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
|
|
実験的：Obesity II Group
Participants with class II and class III obesity (BMI > 35 kg/m²)
|
Participants received 187.5 mL of a ready-to-drink oral nutritional supplement (Nutridrink Protein).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postprandial hormonal response: GLP-1
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
Postprandial changes in serum glucose-dependent insulinotropic polypeptide (GIP) (pg/mL).
|
24 months (analyzes were performed throughout the study period).
|
|
Postprandial hormonal response: cholecystokinin.
時間枠：24 months (analyzes were performed throughout the study period).
|
Postprandial changes in serum cholecystokinin (pg/mL).
|
24 months (analyzes were performed throughout the study period).
|
|
Postprandial hormonal response: omentin.
時間枠：24 months (analyzes were performed throughout the study period).
|
Postprandial changes in serum omentin (ng/mL).
|
24 months (analyzes were performed throughout the study period).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Laboratory parameters: hemoglobin.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Fasting glucose concentration (mg/dL)
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: insulin.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Alanine aminotransferase activity (U/L).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: AST.
時間枠：24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Aspartate aminotransferase activity (U/L).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: creatinine.
時間枠：24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Creatinine concentration (mg/dL).
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: uric acid.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
Laboratory parameters assessed from fasting blood samples.
Lipid profile parameters: HDL cholesterol.
|
24 months (analyzes were performed throughout the study period).
|
|
Laboratory parameters: TG.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
Assessment of lean body mass (kg).
|
24 months (analyzes were performed throughout the study period).
|
|
Physical activity
時間枠：24 months (analyzes were performed throughout the study period).
|
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
時間枠：24 months (analyzes were performed throughout the study period).
|
Resting Energy Expenditure: REE was measured using indirect calorimetry (Q-NRG+, COSMED).
|
24 months (analyzes were performed throughout the study period).
|
|
Dietary habits
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
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.
時間枠：24 months (analyzes were performed throughout the study period).
|
Complete blood count assessed from fasting venous blood samples, including platelet count ×10^3/µL.
|
24 months (analyzes were performed throughout the study period).
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Lucyna Ostrowska, Professor、Department of Dietetics and Clinical Nutrition Medical University of Bialystok
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年4月8日
一次修了 (実際)
2026年4月14日
研究の完了 (実際)
2026年4月14日
試験登録日
最初に提出
2026年5月12日
QC基準を満たした最初の提出物
2026年5月28日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年5月28日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- B.SUB.24.251
- ADN.614.2.2024 (その他の識別子：Medical University of Bialystok)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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