- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07627802
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.
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Poland
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Bialystok, Poland, 폴란드, 15-089
- Medical University of Bialystok
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Normal Body Weight Group
Participants with normal body weight (BMI: 19-24.9
kg/m2)
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Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
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실험적: Overweight Group
Participants with overweight (BMI: 25-29.9
kg/m2)
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Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
|
실험적: 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.
|
|
실험적: Obesity II Group
Participants with class II and class III obesity (BMI > 35 kg/m2)
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Participants consumed 187.5 mL of the oral nutritional supplement Nutridrink Protein during the study procedure.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postprandial serum ghrelin concentration
기간: 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).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hemoglobin concentration
기간: 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).
|
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White blood cell count
기간: 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
기간: 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).
|
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Fasting glucose concentration
기간: 24 months (analyzes were performed throughout the study period).
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Glucose level (mg/dL) measured in fasting blood samples.
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24 months (analyzes were performed throughout the study period).
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Fasting insulin concentration
기간: 24 months (analyzes were performed throughout the study period).
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Insulin level (µIU/mL) measured in fasting blood samples.
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24 months (analyzes were performed throughout the study period).
|
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Total cholesterol concentration
기간: 24 months (analyzes were performed throughout the study period).
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Total cholesterol (mg/dl) measured in fasting blood samples.
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24 months (analyzes were performed throughout the study period).
|
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C-reactive protein concentration
기간: 24 months (analyzes were performed throughout the study period).
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CRP level (mg/L) measured in fasting blood samples.
|
24 months (analyzes were performed throughout the study period).
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Alanine aminotransferase activity
기간: 24 months (analyzes were performed throughout the study period).
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ALT level (U/L) measured in serum.
|
24 months (analyzes were performed throughout the study period).
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Aspartate aminotransferase activity
기간: 24 months (analyzes were performed throughout the study period).
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AST level (U/L) measured in serum.
|
24 months (analyzes were performed throughout the study period).
|
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Serum uric acid concentration
기간: 24 months (analyzes were performed throughout the study period).
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Uric acid level (mg/dL).
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24 months (analyzes were performed throughout the study period).
|
|
Serum creatinine concentration
기간: 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
기간: 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).
|
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Body fat percentage measured by DEXA
기간: 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
기간: 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).
|
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Visceral adipose tissue measured by DEXA
기간: 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).
|
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Subcutaneous adipose tissue measured by DEXA
기간: 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).
|
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Android fat percentage measured by DEXA
기간: 24 months (analyzes were performed throughout the study period).
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Android fat percentage (%) assessed using dual-energy X-ray absorptiometry (DEXA).
|
24 months (analyzes were performed throughout the study period).
|
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Gynoid fat percentage measured by DEXA
기간: 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).
|
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Dietary habits score (QEB questionnaire)
기간: 24 months (analyzes were performed throughout the study period).
|
Score from standardized Questionnaire of Eating Behaviour (QEB).
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24 months (analyzes were performed throughout the study period).
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Cognitive restraint, uncontrolled eating, and emotional eating scores (TFEQ-R18)
기간: 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).
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24 months (analyzes were performed throughout the study period).
|
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Hunger and satiety ratings
기간: 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).
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Physical activity level (IPAQ score)
기간: 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).
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Quality of life score (WHOQOL-BREF)
기간: 24 months (analyzes were performed throughout the study period).
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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).
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Resting energy expenditure measured by indirect calorimetry
기간: 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).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Lucyna Ostrowska, Professor, Department of Dietetics and Clinical Nutrition Medical University of Bialystok
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B.SUB.24.112
- AZN.614.1.2024 (기타 보조금/기금 번호: Medical University of Bialystok)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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