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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03736551
Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study (MIX-UP)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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London, Reino Unido, SE5 9RS
- King's College Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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.
|
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.
|
Comparador activo: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Retention rate of at least 60% in the intervention group
Periodo de tiempo: 6 months
|
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
Periodo de tiempo: 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.
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 6 months
|
change in weight from baseline to 6 months
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6 months
|
kidney function (eGFR ml/min CKD EPI equation)
Periodo de tiempo: 6 months
|
monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.
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6 months
|
Waist circumference (cm)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months
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distance walked (m) in 6 minutes
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6 months
|
Exercise capacity - sit to stand 60
Periodo de tiempo: 6 months
|
number (count) of sit to stand movements in 60 seconds
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6 months
|
Proteinuria
Periodo de tiempo: 6 months
|
urinary protein to creatinine ratio
|
6 months
|
Total Cholesterol
Periodo de tiempo: 6 months
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plasma total cholesterol concentration
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6 months
|
Triglycerides
Periodo de tiempo: 6 months
|
plasma triglycerides concentration
|
6 months
|
LDL cholesterol
Periodo de tiempo: 6 months
|
plasma LDL cholesterol concentration
|
6 months
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HDL cholesterol
Periodo de tiempo: 6 months
|
plasma HDL cholesterol concentration
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Helen L MacLaughlin, PhD, King's College Hospital NHS Fundation Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KCH17-027
- 202350 (Identificador de registro: IRAS)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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