- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07740928
MedDiet in Kidney Transplant Recipients (MedDiet_KT)
6-Week Mediterranean Diet Intervention on Dietary Adherence, Body Composition, and Physical Function in Kidney Transplant Recipients: A Pilot Randomized Controlled Trial
In recent years, increasing attention has been directed toward the role of diet and lifestyle factors in influencing graft function and patient survival after kidney transplantation (KT). Among the dietary patterns investigated, the Mediterranean diet (MedDiet) is among most studied diets in KT recipients. Data from observational studies show that greater adherence to the MedDiet is beneficial in kidney transplant recipients and is associated with improved lipid profile, lower oxidative stress, less frequent new-onset diabetes mellitus after transplantation, metabolic syndrome, better kidney function, and mortality. Unfortunately, adherence to MedDiet in kidney transplant recipients is low, and ranges between 25 % and 44.7%. Data from a Dutch cross-sectional study showed that higher levels of food literacy are associated with better adherence to MedDiet. Nevertheless, evidence from randomized dietary interventions aimed at improving MedDiet adherence in this population remains limited. Therefore, the aim of our pilot randomized controlled trial was to evaluate whether a six-week MedDiet intervention could improve adherence to the Mediterranean dietary pattern, assessed using the Mediterranean Diet Adherence Screener (MEDAS), and to explore the effects of MedDiet on body composition and physical function. We conducted an interventional, randomized study at the Kidney Transplantation Centre, Department of Nephrology, University Medical Centre Ljubljana. The intervention duration was six weeks and was performed by a Master's student in nutrition. We included kidney transplant recipients undergoing regular follow-up at the Kidney Transplantation Centre. Patients were invited to participate verbally via telephone contact one week prior to their scheduled physician appointment. Participation was voluntary and confirmed by a signed informed consent. The following exclusion criteria were applied: body mass index (BMI) > 25 kg/m², age > 45 years, female sex, serum creatinine > 250 µmol/L, a MEDAS score ≥ 10 points, and systolic blood pressure > 160 mmHg. Patients were randomized to the intervention and control group.
The primary study outcome was the MEDAS score. Secondary outcomes were lean tissue index (LTI; kg/m²), fat tissue index (FTI; kg/m²), handgrip strength (kg), and chair-stand performance (number of repetitions).
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ljubljana, 슬로베니아, 1000
- UMC Ljubljana
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 18 years old
- male
- kidney transplant recipient
Exclusion Criteria:
- body mass index (BMI) > 25 kg/m²
- age > 45 years
- female sex
- serum creatinine > 250 µmol/L,
- a MEDAS score ≥ 10 points, and systolic blood pressure > 160 mmHg
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention (MedDiet) group
Med Diet group
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intervention with Mediterranean Diet
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간섭 없음: Control arm
No specific dietary intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mediterranean Diet Adherence Screener (MEDAS)
기간: 6 weeks
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adherence to the Mediterranean Diet was measured using the MEDAS before and after the 6 week intervention
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6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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lean tissue index (LTI; kg/m²)
기간: 6 weeks
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6 weeks
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fat tissue index (FTI; kg/m²)
기간: 6 weeks
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6 weeks
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handgrip strength (kg)
기간: 6 weeks
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6 weeks
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chair-stand test
기간: 6 weeks
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30-second chair-stand performance (number of repetitions)
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6 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Ying T, Shi B, Kelly PJ, Pilmore H, Clayton PA, Chadban SJ. Death after Kidney Transplantation: An Analysis by Era and Time Post-Transplant. J Am Soc Nephrol. 2020 Dec;31(12):2887-2899. doi: 10.1681/ASN.2020050566. Epub 2020 Sep 9.
- Billany RE, Bishop NC, Castle EM, Graham-Brown MPM, Greenwood SA, Lightfoot CJ, Wilkinson TJ. Physical activity interventions in adult kidney transplant recipients: an updated systematic review and meta-analysis of randomized controlled trials. Ren Fail. 2025 Dec;47(1):2480246. doi: 10.1080/0886022X.2025.2480246. Epub 2025 Mar 27.
- Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
유용한 링크
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 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. .