Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06618859

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: TRE

Active Control

Behavioral

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

Primary outcomes

  1. Change in urine albumin/creatinine ratio (UACR)

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

    Measured by 24h urine collection

Secondary outcomes

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

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

    Measured in clinical chemistry

  2. Change in blood pressure

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

    Measured by 24h ambulatory blood pressure monitoring (ABPM)

  3. Change in systolic and diastolic blood pressure

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

    Measured with an arm cuff in the sitting position

  4. Change in body fat mass and regional distribution

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

    Measured by dual-energy X-ray absorptiometry (DXA)

  5. Change in body fat mass

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

    Measured by bioelectrical impedance (BIA)

  6. Change in fasting glucose

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

    Measured in clinical chemistry

  7. Change in glucose excursion

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

    Measured by continuous glucose monitoring (CGM)

  8. Change in physical activity

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

    Measured by actigraphy

  9. Change in sleep/wake cycles

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

    Measured by actigraphy

  10. Change in sleep quality

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

    Measured by the Pittsburgh Sleep Quality Index (PSQI, range 0-21)

  11. Change in eating duration

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

    Duration from the first to last caloric intake over the 24h cycle

  12. Change in weight

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

    Body weight (kg)

  13. Change in lipid profile (concentration of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)

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

    Measured in clinical chemistry

  14. Change in blood hormone profile

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

    Measured in clinical chemistry

  15. Incidence of adverse events in response to the randomized intervention

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

    Adverse events graded after the Common Terminology Criteria for Adverse Events version 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Faivre, MD, PhD

CONTACT

[email protected]

+41-79-5534361

Delal Dalga, MD, PhD

CONTACT

[email protected]

+41-22-3723311

Sponsors and collaborators

Lead sponsor

de Seigneux Sophie

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

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

Acronym: TRECK

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.