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Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study (MIX-UP)

4. september 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 5:2 diet
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)
Adfærdsmæssigt: Renal Weight Management Programme
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.
Aktiv komparator: 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.
Adfærdsmæssigt: Renal Weight Management Programme
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Retention rate of at least 60% in the intervention group
Tidsramme: 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.
6 months
Number of Adverse Events following intermittent very low energy diet
Tidsramme: 6 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria
Tidsramme: 1 year
at least 50% of those meeting the referral criteria and are approached to participant, consent to participating in the study
1 year
Compliance with dietary intervention from dietary records
Tidsramme: 6 months
at least 70% compliance with prescribed diet
6 months
Weight change (kg)
Tidsramme: 6 months
change in weight from baseline to 6 months
6 months
kidney function (eGFR ml/min CKD EPI equation)
Tidsramme: 6 months
monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.
6 months
Waist circumference (cm)
Tidsramme: 6 months
change in waist circumference measured in cm at level of umbilicus
6 months
Body composition
Tidsramme: 6 months
lean and fat mass (kg) estimated by bioelectrical impedance analysis
6 months
Exercise capacity - 6 minute timed walk test
Tidsramme: 6 months
distance walked (m) in 6 minutes
6 months
Exercise capacity - sit to stand 60
Tidsramme: 6 months
number (count) of sit to stand movements in 60 seconds
6 months
Proteinuria
Tidsramme: 6 months
urinary protein to creatinine ratio
6 months
Total Cholesterol
Tidsramme: 6 months
plasma total cholesterol concentration
6 months
Triglycerides
Tidsramme: 6 months
plasma triglycerides concentration
6 months
LDL cholesterol
Tidsramme: 6 months
plasma LDL cholesterol concentration
6 months
HDL cholesterol
Tidsramme: 6 months
plasma HDL cholesterol concentration
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

King's College Hospital NHS Trust

Efterforskere

  • Ledende efterforsker: Helen L MacLaughlin, PhD, King's College Hospital NHS Fundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. oktober 2017

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Faktiske)

6. juni 2019

Datoer for studieregistrering

Først indsendt

1. august 2018

Først indsendt, der opfyldte QC-kriterier

7. november 2018

Først opslået (Faktiske)

9. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2020

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KCH17-027
  • 202350 (Registry Identifier: IRAS)

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