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.

Study Overview

• Status: Completed
• Conditions: Obesity; Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: 5:2 diet; Behavioral: Renal Weight Management Programme

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate of at least 60% in the intervention group	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	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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: weight loss; intermittent fasting
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: KCH17-027; 202350 (Registry Identifier: IRAS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No