Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study

NCT03736551 | Completed

• 2 other identifiers: KCH17-027202350
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Obesity

Keywords

intermittent fasting; weight loss

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

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

  1 year

• Compliance with dietary intervention from dietary records

  6 months

• Weight change (kg)

  6 months

• kidney function (eGFR ml/min CKD EPI equation)

  6 months

• Waist circumference (cm)

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: 5:2 diet; Behavioral: Renal Weight Management Programme

Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Renal Weight Management Programme

Interventions

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)

Intervention

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.

Intervention; Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-75 years
• KDIGO defined CKD (all categories)
• BMI ≥30kg/m2
• able to provide written informed consent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Obesity; Intermittent Fasting; Weight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Helen L MacLaughlin, PhD

  King's College Hospital NHS Fundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study outcome measures performed by assessor blinded to treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel arm, single blinded, randomised controlled feasibility study

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: November 9, 2018
• Study Start: October 25, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 6, 2019
• Last Updated: September 7, 2020

Record last verified: 2018-07

Locations

GB (1)