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Completed

NCT Number: NCT03736551

Intermittent Low Energy Diet in 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.

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Key information

Conditions

Chronic Kidney Diseases Behavior Body Weight Body Weight Changes Chronic Disease Disease Attributes Fasting Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intermittent Fasting Kidney Diseases Male Urogenital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College Hospital

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5:2 diet

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Retention rate of at least 60% in the intervention group

    Time frame: 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.

  2. Number of Adverse Events following intermittent very low energy diet

    Time frame: 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.

Secondary outcomes

  1. Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria

    Time frame: 1 year

    at least 50% of those meeting the referral criteria and are approached to participant, consent to participating in the study

  2. Compliance with dietary intervention from dietary records

    Time frame: 6 months

    at least 70% compliance with prescribed diet

  3. Weight change (kg)

    Time frame: 6 months

    change in weight from baseline to 6 months

  4. kidney function (eGFR ml/min CKD EPI equation)

    Time frame: 6 months

    monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.

  5. Waist circumference (cm)

    Time frame: 6 months

    change in waist circumference measured in cm at level of umbilicus

  6. Body composition

    Time frame: 6 months

    lean and fat mass (kg) estimated by bioelectrical impedance analysis

  7. Exercise capacity - 6 minute timed walk test

    Time frame: 6 months

    distance walked (m) in 6 minutes

  8. Exercise capacity - sit to stand 60

    Time frame: 6 months

    number (count) of sit to stand movements in 60 seconds

  9. Proteinuria

    Time frame: 6 months

    urinary protein to creatinine ratio

  10. Total Cholesterol

    Time frame: 6 months

    plasma total cholesterol concentration

  11. Triglycerides

    Time frame: 6 months

    plasma triglycerides concentration

  12. LDL cholesterol

    Time frame: 6 months

    plasma LDL cholesterol concentration

  13. HDL cholesterol

    Time frame: 6 months

    plasma HDL cholesterol concentration

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

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

Acronym: MIX-UP

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 9, 2018
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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