Chronic kidney disease (CKD) affects approximately 12 to 15% of adults worldwide, with an increasing incidence expected. Major causes include diabetic nephropathy, hypertension, and various glomerulonephritis. Proteinuria is a key factor in identifying and assessing the risk of CKD progression. The precise pathophysiology of CKD is not fully understood, but recent research highlights metabolic alterations, particularly in lipid and glucose metabolism. CKD progression is influenced by diet, as evidenced by recent studies. Interventions such as the ketogenic diet and time-restricted feeding show promising results in improving metabolism and may have beneficial effects on CKD. Our study aims to evaluate the impact of time-restricted eating (TRE) on proteinuria, the decline in glomerular filtration rate, and weight loss in patients with moderate CKD with albuminuria (KDIGO stage 2-3). This will allow us to better understand the efficacy of this dietary approach tailored to the individual habits of participants. The primary outcome measure will be albuminuria before and after the 12-week intervention. Secondary outcome measures will include the impact of fasting on blood pressure as assessed by 24-hour ambulatory monitoring, body composition evaluated by DXA and BIA, continuous glucose monitoring, and blood hormone profiles. Additionally, the feasibility and safety of TRE in this population will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Participants will be advised to consume meals and calorie-containing drinks only during a window of 8 hours, to be self-selected by the participant and advised by the investigators based on their daily routine and eating habits during the run-in phase.
Participants will be advised to keep the same eating rhythm and timing of meals per day during the intervention.
University Hospital, Geneva
Geneva, Switzerland
RECRUITINGChange in urine albumin/creatinine ratio (UACR)
Measured by 24h urine collection
Time frame: From randomization to close-out visit (12 weeks)
Change in creatinine- and cystatin-estimated glomerular filtration rate (eGFR)
Measured in clinical chemistry
Time frame: From randomization to close-out visit (12 weeks)
Change in blood pressure
Measured by 24h ambulatory blood pressure monitoring (ABPM)
Time frame: From randomization to close-out visit (12 weeks)
Change in systolic and diastolic blood pressure
Measured with an arm cuff in the sitting position
Time frame: From randomization to close-out visit (12 weeks)
Change in body fat mass and regional distribution
Measured by dual-energy X-ray absorptiometry (DXA)
Time frame: From randomization to close-out visit (12 weeks)
Change in body fat mass
Measured by bioelectrical impedance (BIA)
Time frame: From randomization to close-out visit (12 weeks)
Change in fasting glucose
Measured in clinical chemistry
Time frame: From randomization to close-out visit (12 weeks)
Change in glucose excursion
Measured by continuous glucose monitoring (CGM)
Time frame: From randomization to close-out visit (12 weeks)
Change in physical activity
Measured by actigraphy
Time frame: From randomization to close-out visit (12 weeks)
Change in sleep/wake cycles
Measured by actigraphy
Time frame: From randomization to close-out visit (12 weeks)
Change in sleep quality
Measured by the Pittsburgh Sleep Quality Index (PSQI, range 0-21)
Time frame: From randomization to close-out visit (12 weeks)
Change in eating duration
Duration from the first to last caloric intake over the 24h cycle
Time frame: From randomization to close-out visit (12 weeks)
Change in weight
Body weight (kg)
Time frame: From randomization to close-out visit (12 weeks)
Change in lipid profile (concentration of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Measured in clinical chemistry
Time frame: From randomization to close-out visit (12 weeks)
Change in blood hormone profile
Measured in clinical chemistry
Time frame: From randomization to close-out visit (12 weeks)
Incidence of adverse events in response to the randomized intervention
Adverse events graded after the Common Terminology Criteria for Adverse Events version 5.0
Time frame: From randomization to close-out visit (12 weeks)
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