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

Sponsor

King's College Hospital NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT03736551

Collaborator

(none)

Enrollment

Location

Arms

19.4

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Obesity	Behavioral: 5:2 diet Behavioral: Renal Weight Management Programme	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel arm, single blinded, randomised controlled feasibility studyParallel arm, single blinded, randomised controlled feasibility study

Masking:

Single (Outcomes Assessor)

Masking Description:

Study outcome measures performed by assessor blinded to treatment arm

Primary Purpose:

Treatment

Official Title:

Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With CKD (MIX UP): Feasibility Study

Actual Study Start Date :

Oct 25, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Jun 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: 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) Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

Arm

Intervention/Treatment

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.

Behavioral: 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)

Behavioral: 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.

Active Comparator: 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.

Behavioral: Renal Weight Management Programme

Outcome Measures

Primary Outcome Measures

Retention rate of at least 60% in the intervention group [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.
Number of Adverse Events following intermittent very low energy diet [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King's College Hospital	London		United Kingdom	SE5 9RS

Sponsors and Collaborators

King's College Hospital NHS Trust

Investigators

Principal Investigator: Helen L MacLaughlin, PhD, King's College Hospital NHS Fundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

King's College Hospital NHS Trust

ClinicalTrials.gov Identifier:

NCT03736551

Other Study ID Numbers:

KCH17-027
202350

First Posted:

Nov 9, 2018

Last Update Posted:

Sep 7, 2020

Last Verified:

Jul 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by King's College Hospital NHS Trust

intermittent fasting

weight loss

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Sep 7, 2020