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

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

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 Overview

• Status: Recruiting
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Behavioral: Time-restricted eating; Behavioral: Active control

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Delal Dalga, MD, PhD; Phone Number: +41-22-3723311; Email: delal.dalga@unige.ch
• Study Contact Backup: Name: Anna Faivre, MD, PhD; Phone Number: +41-79-5534361; Email: anna.faivre@hug.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • University Hospital, Geneva
    • Contact: Anna Faivre, MD, PhD; Phone Number: +41-79-5534361; Email: anna.faivre@hug.ch
    • Contact: Sophie de Seigneux, MD, PhD; Phone Number: +41-22-3723311; Email: sophie.deseigneux@hug.ch
    • Sub-Investigator: Anna Faivre, MD, PhD
    • Sub-Investigator: Tinh-Hai Collet, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active control	Behavioral: Active control; Participants will be advised to keep the same eating rhythm and timing of meals per day during the intervention.
Experimental: Time-restricted eating	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.; Other Names: TRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urine albumin/creatinine ratio (UACR)	Measured by 24h urine collection	From randomization to close-out visit (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in creatinine- and cystatin-estimated glomerular filtration rate (eGFR)	Measured in clinical chemistry	From randomization to close-out visit (12 weeks)
Change in blood pressure	Measured by 24h ambulatory blood pressure monitoring (ABPM)	From randomization to close-out visit (12 weeks)
Change in systolic and diastolic blood pressure	Measured with an arm cuff in the sitting position	From randomization to close-out visit (12 weeks)
Change in body fat mass and regional distribution	Measured by dual-energy X-ray absorptiometry (DXA)	From randomization to close-out visit (12 weeks)
Change in body fat mass	Measured by bioelectrical impedance (BIA)	From randomization to close-out visit (12 weeks)
Change in fasting glucose	Measured in clinical chemistry	From randomization to close-out visit (12 weeks)
Change in glucose excursion	Measured by continuous glucose monitoring (CGM)	From randomization to close-out visit (12 weeks)
Change in physical activity	Measured by actigraphy	From randomization to close-out visit (12 weeks)
Change in sleep/wake cycles	Measured by actigraphy	From randomization to close-out visit (12 weeks)
Change in sleep quality	Measured by the Pittsburgh Sleep Quality Index (PSQI, range 0-21)	From randomization to close-out visit (12 weeks)
Change in eating duration	Duration from the first to last caloric intake over the 24h cycle	From randomization to close-out visit (12 weeks)
Change in weight	Body weight (kg)	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	From randomization to close-out visit (12 weeks)
Change in blood hormone profile	Measured in clinical chemistry	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	From randomization to close-out visit (12 weeks)

Collaborators and Investigators

• Sponsor: de Seigneux Sophie
• Collaborators: University Hospital, Geneva
• Investigators: Principal Investigator: Sophie de Seigneux, MD, PhD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2023-02172

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No