Obesity Clinical Trial
Official title:
Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With 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.
n/a
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