Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study (MIX-UP)
2020년 9월 4일 업데이트: King's College Hospital NHS Trust
Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With CKD (MIX UP): Feasibility Study
This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology.
Patients will be invited to participate in the parallel arm, single blinded, randomised controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The experimental arm involves an intermittent modified fasting regimen consisting of VLED (600 kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be the standard renal WMP with a continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day.
The feasibility outcomes are: recruitment rate >50%; intervention retention rate at 6 months >60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety, body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will be made at baseline, midpoint, and twice at endpoint.
연구 개요
연구 유형
중재적
등록 (실제)
13
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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London, 영국, SE5 9RS
- King's College Hospital
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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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- aged 18-75 years
- KDIGO defined CKD (all categories)
- BMI ≥30kg/m2
- able to provide written informed consent in English
Exclusion Criteria:
- pregnant or breastfeeding women
- conservatively managed CKD stage 5
- palliative or active treatment for cancer
- unstable chronic liver disease
- type 1 diabetes and type 2 diabetes controlled with anti-hyperglycaemic medication
- previous bariatric surgery
- unable to provide written informed consent
- significant psychiatric disorder or uncontrolled depression
- participated in a weight management drug trial in the previous 3 months
- uncontrolled epilepsy
- alcohol or substance abuse
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention
The intervention arm will involve standard care plus an intermittent modified fasting regimen consisting of a very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet).
All dietary intake on modified fasting days will be from LighterLife foodpacks, (4 x 150 kcal portions/day presented as milkshakes, cereal bars, soups and modified meals such as spaghetti bolognese, or macaroni cheese) providing ~600 kcal/day and 100% of the RNI for vitamins and minerals.
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very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet)
Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure.
In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing.
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활성 비교기: Standard Care
Renal Weight management Programme - Patients will attend individual appointments with the specialist dietitian and physiotherapist once a month, for 6 months.
Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure (9).
In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing.
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Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure.
In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Retention rate of at least 60% in the intervention group
기간: 6 months
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Patients attending at least 80% of monthly clinic visits, including the baseline and final study visits, and remaining compliant with the 2 consecutive days VLED throughout the 6 month intervention will be considered "completers" and count as being retained in the intervention group at 6 months.
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6 months
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Number of Adverse Events following intermittent very low energy diet
기간: 6 months
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record of all adverse events including but not limited to nausea, constipation and/or diarrhoea, dehydration, hypoglycaemia, lethargy & fatigue, headaches, gallstones and gout.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria
기간: 1 year
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at least 50% of those meeting the referral criteria and are approached to participant, consent to participating in the study
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1 year
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Compliance with dietary intervention from dietary records
기간: 6 months
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at least 70% compliance with prescribed diet
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6 months
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Weight change (kg)
기간: 6 months
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change in weight from baseline to 6 months
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6 months
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kidney function (eGFR ml/min CKD EPI equation)
기간: 6 months
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monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.
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6 months
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Waist circumference (cm)
기간: 6 months
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change in waist circumference measured in cm at level of umbilicus
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6 months
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Body composition
기간: 6 months
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lean and fat mass (kg) estimated by bioelectrical impedance analysis
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6 months
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Exercise capacity - 6 minute timed walk test
기간: 6 months
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distance walked (m) in 6 minutes
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6 months
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Exercise capacity - sit to stand 60
기간: 6 months
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number (count) of sit to stand movements in 60 seconds
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6 months
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Proteinuria
기간: 6 months
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urinary protein to creatinine ratio
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6 months
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Total Cholesterol
기간: 6 months
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plasma total cholesterol concentration
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6 months
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Triglycerides
기간: 6 months
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plasma triglycerides concentration
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6 months
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LDL cholesterol
기간: 6 months
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plasma LDL cholesterol concentration
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6 months
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HDL cholesterol
기간: 6 months
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plasma HDL cholesterol concentration
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Helen L MacLaughlin, PhD, King's College Hospital NHS Fundation Trust
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 (실제)
2017년 10월 25일
기본 완료 (실제)
2018년 12월 31일
연구 완료 (실제)
2019년 6월 6일
연구 등록 날짜
최초 제출
2018년 8월 1일
QC 기준을 충족하는 최초 제출
2018년 11월 7일
처음 게시됨 (실제)
2018년 11월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 9월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 9월 4일
마지막으로 확인됨
2018년 7월 1일
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. .