Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study

Obesity Clinical Trial

— MIX-UP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736551
• Other study ID #: KCH17-027
• Secondary ID: 202350
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: June 6, 2019

Study information

• Verified date: July 2018
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 6, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic

Intervention

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)
• 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.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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