Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study (MIX-UP)
Chronic Kidney Diseases, Obesity
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring intermittent fasting, weight loss
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
Sites / Locations
- King's College Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention
Standard Care
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.
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.