Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsorde Seigneux Sophie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical criteria

Adult men and women

Chronic Kidney Disease with KDIGO stage G2 and G3 defined by a Glomerular Filtration Rate between 30 and 90 mL/min/1.73m2

Albuminuria stage A2 or A3, but without nephrotic-range proteinuria: 3 to 200 mg/mmol

Disqualifiers

Clinical criteria

Pregnant and breastfeeding women, plans for maternity during the study

Eating disorder(s)

Other diets: low-carb, ketogenic diet, hypocaloric diets (eviction for food intolerances, vegan/vegetarian diet are not excluded)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time-restricted eating

    Behavioral

    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.

  • Active control

    Behavioral

    Participants will be advised to keep the same eating rhythm and timing of meals per day during the intervention.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Time-restricted eatingExperimental treatment 1 intervention
Group B: Active controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in urine albumin/creatinine ratio (UACR)

Measured by 24h urine collection

Time frame
From randomization to close-out visit (12 weeks)

Secondary outcomes

1

Change in creatinine- and cystatin-estimated glomerular filtration rate (eGFR)

Measured in clinical chemistry

Time frame
From randomization to close-out visit (12 weeks)
2

Change in blood pressure

Measured by 24h ambulatory blood pressure monitoring (ABPM)

Time frame
From randomization to close-out visit (12 weeks)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

de Seigneux Sophie

Lead sponsor

University Hospital, Geneva

Sponsor institution

University Hospital, Geneva

Collaborator