Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study (MIX-UP)
2020年9月4日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
13
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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London、イギリス、SE5 9RS
- King's College Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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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 |
|---|---|---|
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Retention rate of at least 60% in the intervention group
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：6 months
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urinary protein to creatinine ratio
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6 months
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Total Cholesterol
時間枠：6 months
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plasma total cholesterol concentration
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6 months
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Triglycerides
時間枠：6 months
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plasma triglycerides concentration
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6 months
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LDL cholesterol
時間枠：6 months
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plasma LDL cholesterol concentration
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6 months
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HDL cholesterol
時間枠：6 months
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plasma HDL cholesterol concentration
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6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Helen L MacLaughlin, PhD、King's College Hospital NHS Fundation Trust
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年10月25日
一次修了 (実際)
2018年12月31日
研究の完了 (実際)
2019年6月6日
試験登録日
最初に提出
2018年8月1日
QC基準を満たした最初の提出物
2018年11月7日
最初の投稿 (実際)
2018年11月9日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月7日
QC基準を満たした最後の更新が送信されました
2020年9月4日
最終確認日
2018年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。