Ghrelin and Nutritional Status After a Standardized Meal.
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.
調査の概要
詳細な説明
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
- 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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Poland
-
Bialystok、Poland、ポーランド、15-089
- Medical University of Bialystok
-
-
参加基準
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
説明
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
研究計画
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 consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
|
実験的：Overweight Group
Participants with overweight (BMI: 25-29.9
kg/m2)
|
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
|
実験的：Obesity I Group
Participants with class I obesity (BMI: 30-34.9
kg/m2)
|
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
|
実験的：Obesity II Group
Participants with class II and class III obesity (BMI > 35 kg/m2)
|
Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
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 serum ghrelin concentration
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hemoglobin concentration
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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).
|
協力者と研究者
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
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- B.SUB.24.112
- AZN.614.1.2024 (その他の助成金/資金番号：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?
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