A Mediterranean Diet-Based Culinary Intervention in Adults With Metabolic Syndrome (CUINAMET)
2026년 7월 13일 업데이트: Rosa Casas, Fundacion Clinic per a la Recerca Biomédica
Impact of a Mediterranean Diet-based Culinary Medicine Intervention on the Reversal of Metabolic Syndrome and Biomarkers of Inflammation, Oxidative Stress, and Aging
Metabolic syndrome is a major public health concern associated with an increased risk of cardiovascular disease, type 2 diabetes, and premature mortality. The Mediterranean diet has consistently demonstrated beneficial effects on metabolic health and is recommended as a dietary strategy for the prevention and management of metabolic syndrome. However, most interventions have focused on conventional nutritional counseling and have paid limited attention to the culinary and gastronomic skills required to translate dietary recommendations into sustainable eating behaviors.
This randomized controlled trial will evaluate the effectiveness of a Mediterranean diet-based nutritional intervention complemented by culinary medicine training sessions compared with a nutritional intervention alone in Spanish adults with metabolic syndrome. The culinary medicine component is designed to enhance participants' food preparation skills, confidence in cooking, and ability to incorporate Mediterranean dietary principles into their daily lives.
Participants will be followed for 6 months to assess changes in metabolic syndrome components and other metabolic health indicators. The study aims to determine whether the integration of culinary medicine education enhances the effectiveness of conventional nutritional counseling in improving metabolic syndrome outcomes and promoting long-term adherence to a Mediterranean dietary pattern
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
120
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Victoria S Pinto Manzo, Msc
- 전화번호: 2907 +34 932275400
- 이메일: victoriasabinap@ub.edu
연구 장소
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Barcelona
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Barcelona, Barcelona, 스페인, 08035
- IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)
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연락하다:
- Victoria S Pinto Manzo, Msc
- 전화번호: 2907 +34 932275400
- 이메일: victoriasabinap@ub.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Men and women
- Age between 30 and 60 years
- Body mass index (BMI) between 20 and 35 kg/m²
Presence of metabolic syndrome defined as having at least three of the following criteria:
- HDL cholesterol <40 mg/dL in men and <50 mg/dL in women
- Fasting glucose >100 mg/dL or use of hypoglycemic agents
- Triglycerides ≥150 mg/dL or use of lipid-lowering medication
- Blood pressure ≥130/85 mmHg
- Waist circumference ≥102 cm in men and ≥88 cm in women
Exclusion Criteria:
- Food allergies or intolerances to foods typical of the Mediterranean diet
- Gluten intolerance or celiac disease
- Adherence to a vegetarian or vegan diet
- Eating disorders (including anorexia nervosa, bulimia nervosa, and binge eating disorder)
- Moderate to severe psychiatric disorders that may compromise adherence to the intervention
- History of cardiovascular events
- BMI >35 kg/m²
- Extreme dietary patterns in the last 3 months (e.g., Atkins diet, very high-protein diets)
- Excessive alcohol consumption (>30 g/day for men and >20 g/day for women)
- Pregnancy or lactation
- Previous culinary training or formal culinary education
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 대조군
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Participants assigned to the control group will receive standard nutritional counseling in Mediterranean diet, consisting of three individual consultations at baseline, 3 months, and 6 months to monitor adherence to dietary recommendations. At each visit, health parameters will be assessed and questionnaires will be administered to evaluate dietary behavior and related outcomes. At baseline, 3 months, and 6 months, participants will undergo the same measurements as the intervention group. After completion of the study, participants in the control group will be provided with the Mediterranean recipe booklet and access to the educational videos on Mediterranean culinary preparations used in the intervention group. |
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실험적: Culinary-Nutritional Intervention Group
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Participants assigned to the culinary-nutritional intervention group will receive three individualized nutritional counseling sessions in Mediterranean diet, at baseline, 3 months, and 6 months, including health assessments and questionnaire administration at each visit. At the baseline visit, participants will receive a Mediterranean recipe booklet. Throughout the intervention, they will also receive educational videos featuring Mediterranean culinary preparations and cooking techniques. In addition, participants will attend nine hands-on culinary medicine workshops over the 6-month intervention period. Workshops will be conducted every two weeks during the first 3 months (six workshops) and monthly during the last 3 months (three workshops). The workshops will focus on Mediterranean diet principles, healthy cooking skills, meal planning, food selection, and preparation of Mediterranean-style recipes to facilitate adherence to the dietary intervention. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in metabolic syndrome components
기간: Baseline, 3 months, and 6 months
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Changes in metabolic syndrome components according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria, including waist circumference, blood pressure, fasting glucose, triglycerides, and HDL cholesterol, measured as continuous variables, using a score ranging from 1 to 5.
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Baseline, 3 months, and 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body weight, fat mass and lean mass
기간: Baseline, 3 months, and 6 months
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Weight in kilograms (kg) using a calibrated electronic scale.
Fat mass and lean mass in kilograms (kg) measured using dual-energy X-ray absorptiometry (DXA).
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Baseline, 3 months, and 6 months
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Body fat
기간: Baseline, 3 months, and 6 months
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Body fat expressed as a percentage (%) measured using dual-energy X-ray absorptiometry (DXA).
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Baseline, 3 months, and 6 months
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Height
기간: Baseline, 3 months, and 6 months
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Height, measured in centimeters (cm) using a wall-mounted stadiometer
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Baseline, 3 months, and 6 months
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Lipid profile
기간: Baseline, 3 months, and 6 months
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Lipid profile including total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), triglycerides (mg/dl), VLDL cholesterol (mg/dl), and non-HDL cholesterol (mg/dl) measured using standard enzymatic methods.
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Baseline, 3 months, and 6 months
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Liver enzymes
기간: Baseline, 3 months, and 6 months
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Liver enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and alkaline phosphatase (ALP), measured in units per liter (U/L) using standard laboratory methods.
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Baseline, 3 months, and 6 months
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Total and direct bilirubin
기간: Baseline, 3 months, and 6 months
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Total and direct bilirubin, measured in micromoles per liter (µmol/L) using standard laboratory methods.
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Baseline, 3 months, and 6 months
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Serum albumin and total protein
기간: Baseline, 3 months, and 6 months
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Serum albumin and total protein, measured in grams per liter (g/L) using standard laboratory methods.
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Baseline, 3 months, and 6 months
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Glycated hemoglobin
기간: Baseline, 3 months, and 6 months
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Glycated hemoglobin (HbA1c), measured as a percentage (%) using standardized laboratory assays.
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Baseline, 3 months, and 6 months
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Dietary intake
기간: Baseline, 3 months, and 6 months
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Dietary intake, assessed using a validated Food Frequency Questionnaire (FFQ) to estimate habitual energy and nutrient intake.
Nutrient and energy intake are expressed in grams per day (g/day), milligrams per day (mg/day), micrograms per day (µg/day), or kilocalories per day (kcal/day), depending on the dietary component evaluated.
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Baseline, 3 months, and 6 months
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Mediterranean diet adherence
기간: Baseline, 3 months, and 6 months
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Mediterranean diet adherence, assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS).
Scores range from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.
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Baseline, 3 months, and 6 months
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Culinary habits
기간: Baseline, 3 months, and 6 months
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Culinary habits, assessed using the Home Cooking Frequency Questionnaire (HCFQ).
The questionnaire evaluates the frequency of home cooking, food preparation behaviors, and culinary skills.
Higher scores indicate greater frequency of home cooking and healthier culinary practices.
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Baseline, 3 months, and 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reduced and oxidized glutathione
기간: Baseline, 3 months, and 6 months
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Reduced and oxidized glutathione (GSH and GSSG), measured in micromoles per liter (µmol/L) using enzymatic or chromatographic methods.
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Baseline, 3 months, and 6 months
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Gut microbiota composition
기간: Baseline, 3 months, and 6 months
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Gut microbiota composition, assessed by 16S ribosomal RNA (16S rRNA) gene sequencing of fecal DNA.
Relative abundance of bacterial taxa is expressed as percentage (%).
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Baseline, 3 months, and 6 months
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Superoxide dismutase
기간: Baseline, 3 months, and 6 months
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Superoxide dismutase (SOD), measured in units per milliliter (U/mL) using standardized enzymatic assays.
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Baseline, 3 months, and 6 months
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F2-isoprostanes
기간: Baseline, 3 months, and 6 months
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F2-isoprostanes, measured in picograms per milliliter (pg/mL) using liquid chromatography-tandem mass spectrometry (LC-MS/MS) or enzyme-linked immunosorbent assay (ELISA).
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Baseline, 3 months, and 6 months
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Malondialdehyde
기간: Baseline, 3 months, and 6 months
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Malondialdehyde (MDA), measured in micromoles per liter (µmol/L) using high-performance liquid chromatography (HPLC) or validated colorimetric assays.
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Baseline, 3 months, and 6 months
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Catalase
기간: Baseline, 3 months, and 6 months
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Catalase (CAT), measured in units per liter (U/L) using standardized enzymatic assays.
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Baseline, 3 months, and 6 months
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Inflammatory biomarkers
기간: Baseline, 3 months, and 6 months
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Inflammatory biomarkers, including tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), monocyte chemoattractant protein-1 (MCP-1), and ghrelin, measured in picograms per milliliter (pg/mL) using multiplex immunoassays or enzyme-linked immunosorbent assay (ELISA).
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Baseline, 3 months, and 6 months
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Adipokines
기간: Baseline, 3 months, and 6 months
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Adipokines, including leptin and visfatin, measured in nanograms per milliliter (ng/mL) using multiplex immunoassays or enzyme-linked immunosorbent assay (ELISA).
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Baseline, 3 months, and 6 months
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Adiponectin
기간: Baseline, 3 months, and 6 months
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Adiponectin, measured in micrograms per milliliter (µg/mL) using enzyme-linked immunosorbent assay (ELISA).
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Baseline, 3 months, and 6 months
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High-sensitivity C-reactive protein
기간: Baseline, 3 months, and 6 months
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High-sensitivity C-reactive protein (hs-CRP), measured in milligrams per liter (mg/L) using immunoturbidimetric or immunoassay methods.
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Baseline, 3 months, and 6 months
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Circulating polyphenols and plasma carotenoids
기간: Baseline, 3 months, and 6 months
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Circulating polyphenols and plasma carotenoids, measured in micromoles per liter (µmol/L) using high-performance liquid chromatography (HPLC) coupled with mass spectrometry.
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Baseline, 3 months, and 6 months
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Urinary polyphenols
기간: Baseline, 3 months, and 6 months
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Urinary polyphenols, measured in milligrams of gallic acid equivalents per gram of creatinine (mg GAE/g creatinine) using the Folin-Ciocalteu method or chromatographic techniques.
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Baseline, 3 months, and 6 months
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Advanced glycation end products
기간: Baseline, 3 months, and 6 months
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Advanced glycation end products (AGEs), measured in nanograms per milliliter (ng/mL) using enzyme-linked immunosorbent assay (ELISA).
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Baseline, 3 months, and 6 months
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Fecal short-chain fatty acids
기간: Baseline, 3 months, and 6 months
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Fecal short-chain fatty acids (SCFAs), including acetate, propionate, and butyrate, measured in micromoles per gram of feces (µmol/g) using gas chromatography with flame ionization detection (GC-FID).
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Baseline, 3 months, and 6 months
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Health-related quality of life
기간: Baseline, 3 months, and 6 months
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Health-related quality of life, assessed using the 36-Item Short Form Health Survey (SF-36).
Scores range from 0 to 100 for each of the eight domains and the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, with higher scores indicating better health-related quality of life.
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Baseline, 3 months, and 6 months
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Physical activity,
기간: Baseline, 3 months, and 6 months
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Physical activity, assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Physical activity is expressed as metabolic equivalent of task (MET)-minutes per week (MET-min/week), with higher values indicating greater levels of physical activity.
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Baseline, 3 months, and 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Rosa M Casas Rodríguez, PhD, IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Bach-Faig A, Berry EM, Lairon D, Reguant J, Trichopoulou A, Dernini S, Medina FX, Battino M, Belahsen R, Miranda G, Serra-Majem L; Mediterranean Diet Foundation Expert Group. Mediterranean diet pyramid today. Science and cultural updates. Public Health Nutr. 2011 Dec;14(12A):2274-84. doi: 10.1017/S1368980011002515.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 3월 1일
연구 완료 (추정된)
2028년 3월 1일
연구 등록 날짜
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
2026년 7월 13일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 13일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HCB/2026/0570
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .