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

Official title

Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria: A Pilot Randomized, Open-label, Double-arm Trial (TRECK)

Overview

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.

Interventions

• Behavioral Time-restricted eating
  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.
• Behavioral Active control
  Participants will be advised to keep the same eating rhythm and timing of meals per day during the intervention.

Primary outcome measures

• Change in urine albumin/creatinine ratio (UACR) [Time frame: From randomization to close-out visit (12 weeks)]

Secondary outcome measures (12)

• Change in creatinine- and cystatin-estimated glomerular filtration rate (eGFR) [Time frame: From randomization to close-out visit (12 weeks)]
• Change in blood pressure [Time frame: From randomization to close-out visit (12 weeks)]
• Change in systolic and diastolic blood pressure [Time frame: From randomization to close-out visit (12 weeks)]
• Change in body fat mass and regional distribution [Time frame: From randomization to close-out visit (12 weeks)]
• Change in body fat mass [Time frame: From randomization to close-out visit (12 weeks)]
• Change in fasting glucose [Time frame: From randomization to close-out visit (12 weeks)]
• Change in glucose excursion [Time frame: From randomization to close-out visit (12 weeks)]
• Change in physical activity [Time frame: From randomization to close-out visit (12 weeks)]
• Change in sleep/wake cycles [Time frame: From randomization to close-out visit (12 weeks)]
• Change in sleep quality [Time frame: From randomization to close-out visit (12 weeks)]
• Change in eating duration [Time frame: From randomization to close-out visit (12 weeks)]
• Change in weight [Time frame: From randomization to close-out visit (12 weeks)]

Eligibility criteria

Inclusion criteria

• 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
• Body mass index 18-40 kg/m2
• Eating window of 12 hours (self-reported and measured during the run-in phase)
• Study-related criteria

• Able to give informed consent and follow the study procedures for the entire duration
• Confident use of a smartphone compatible with the MyFoodRepo app (iOS, Android) and able to take regular pictures of food/drinks

Exclusion criteria

• 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)
• Uncontrolled blood pressure (> 160/100 mmHg)
• Diabetes with hypoglycemic drug(s) will be excluded, however those with impaired glucose tolerance (prediabetes, as defined by the American Diabetes Association) or diabetes with no risk of hypoglycemia (i.e. treated with non-hypoglycemic drugs or without medication) will be included
• Oral corticosteroids
• Uncontrolled diabetes HbA1c > 8.5%
• Active cancer and/or oncologic treatment over the previous 12 months
• Major mental illness
• Consumption of > 7 standard units of alcohol per week for women and > 14 standard units of alcohol per week for men
• Shift work, such as evening shifts or night shifts planned during the study
• Travel/trip to a different time zone (≥ 2-hour time difference) planned during the study
• Study-related criteria and other interventions

• Recent treatment modification in the last 3 months, including but not limited to ACE blockers, SLGT2i, finerenone
• Patients with recent glomerulonephritis diagnosis on more than 2 immunosuppressive drugs
• Patients with kidney transplant in the last past year
• Enrolled in another interventional clinical trial (medication, medical device) over the previous 1 month and planned during the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• University Hospital, Geneva — Geneva

Identifiers

NCT: NCT06618859 · 2023-02172

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗