Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases; Obesity

• Registration Number: NCT03736551
• Lead Sponsor: King's College Hospital NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-25
• Status Verified: 2018-07
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-06
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Compliance with dietary intervention from dietary records	6 months	at least 70% compliance with prescribed diet
Body composition	6 months	lean and fat mass (kg) estimated by bioelectrical impedance analysis
LDL cholesterol	6 months	plasma LDL cholesterol concentration
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
Waist circumference (cm)	6 months	change in waist circumference measured in cm at level of umbilicus
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
Triglycerides	6 months	plasma triglycerides concentration
HDL cholesterol	6 months	plasma HDL cholesterol concentration
Weight change (kg)	6 months	change in weight from baseline to 6 months
Total Cholesterol	6 months	plasma total cholesterol concentration
kidney function (eGFR ml/min CKD EPI equation)	6 months	monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.
Exercise capacity - 6 minute timed walk test	6 months	distance walked (m) in 6 minutes

Trial Locations

Locations (1)

King's College Hospital; 🇬🇧 London, United Kingdom