An interventional study of 5:2 diet and Renal Weight Management Programme in Chronic Kidney Diseases and Obesity, sponsored by King's College Hospital NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-07.
Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 13 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
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
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
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)
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.
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.
Time frame: 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.
Time frame: 6 months
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
Time frame: 1 year
Compliance with dietary intervention from dietary records
at least 70% compliance with prescribed diet
Time frame: 6 months
Weight change (kg)
change in weight from baseline to 6 months
Time frame: 6 months
kidney function (eGFR ml/min CKD EPI equation)
monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.
Time frame: 6 months
Waist circumference (cm)
change in waist circumference measured in cm at level of umbilicus
Time frame: 6 months
Body composition
lean and fat mass (kg) estimated by bioelectrical impedance analysis
Time frame: 6 months
Exercise capacity - 6 minute timed walk test
distance walked (m) in 6 minutes
Time frame: 6 months
Exercise capacity - sit to stand 60
number (count) of sit to stand movements in 60 seconds
Time frame: 6 months
Proteinuria
urinary protein to creatinine ratio
Time frame: 6 months
Total Cholesterol
plasma total cholesterol concentration
Time frame: 6 months
Triglycerides
plasma triglycerides concentration
Time frame: 6 months
LDL cholesterol
plasma LDL cholesterol concentration
Time frame: 6 months
HDL cholesterol
plasma HDL cholesterol concentration
Time frame: 6 months
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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King's College Hospital NHS Trust