Clinical trial NCT03736551: Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study
Official title: Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With CKD (MIX UP): Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Obesity
Keywords: intermittent fasting
weight loss
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel arm, single blinded, randomised controlled feasibility study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Retention rate of at least 60% in the intervention group
timeFrame: 6 months
measure: Number of Adverse Events following intermittent very low energy diet
timeFrame: 6 months
Secondary outcomes:
measure: Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria
timeFrame: 1 year
measure: Compliance with dietary intervention from dietary records
timeFrame: 6 months
measure: Weight change (kg)
timeFrame: 6 months
measure: kidney function (eGFR ml/min CKD EPI equation)
timeFrame: 6 months
measure: Waist circumference (cm)
timeFrame: 6 months
measure: Body composition
timeFrame: 6 months
measure: Exercise capacity - 6 minute timed walk test
timeFrame: 6 months
measure: Exercise capacity - sit to stand 60
timeFrame: 6 months
measure: Proteinuria
timeFrame: 6 months
measure: Total Cholesterol
timeFrame: 6 months
measure: Triglycerides
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
measure: HDL cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College Hospital NHS Fundation Trust
name: Helen L MacLaughlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: