Renal Insufficiency, ChronicTRECKNCT06618859
Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria
A study testing Time-restricted eating in people with Renal Insufficiency, Chronic, run by de Seigneux Sophie at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Dec 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital, Geneva
Geneva, 1211
Sophie de Seigneux, MD, PhD, +41-22-3723311, sophie.deseigneux@hug.ch
Anna Faivre, MD, PhD, +41-79-5534361, anna.faivre@hug.ch
About this study
Official title: 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.
Read more
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.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Time-restricted eating, Active control
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Also called TRE
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 controlBehavioural
Participants will be advised to keep the same eating rhythm and timing of meals per day during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating | Experimental | Not described Receives: Behavioral: Time-restricted eating |
| Active control | Active comparator | Not described Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine albumin/creatinine ratio (UACR)
Measured by 24h urine collection
Measured: From randomization to close-out visit (12 weeks)
Secondary outcomes (15)
Change in creatinine- and cystatin-estimated glomerular filtration rate (eGFR)
Measured in clinical chemistry
Measured: From randomization to close-out visit (12 weeks)
Change in blood pressure
Measured by 24h ambulatory blood pressure monitoring (ABPM)
Measured: From randomization to close-out visit (12 weeks)
Change in systolic and diastolic blood pressure
Measured with an arm cuff in the sitting position
Measured: From randomization to close-out visit (12 weeks)
Change in body fat mass and regional distribution
Measured by dual-energy X-ray absorptiometry (DXA)
Measured: From randomization to close-out visit (12 weeks)
Change in body fat mass
Measured by bioelectrical impedance (BIA)
Measured: From randomization to close-out visit (12 weeks)
Change in fasting glucose
Measured in clinical chemistry
Measured: From randomization to close-out visit (12 weeks)
Change in glucose excursion
Measured by continuous glucose monitoring (CGM)
Measured: From randomization to close-out visit (12 weeks)
Change in physical activity
Measured by actigraphy
Measured: From randomization to close-out visit (12 weeks)
Change in sleep/wake cycles
Measured by actigraphy
Measured: From randomization to close-out visit (12 weeks)
Change in sleep quality
Measured by the Pittsburgh Sleep Quality Index (PSQI, range 0-21)
Measured: From randomization to close-out visit (12 weeks)
Change in eating duration
Duration from the first to last caloric intake over the 24h cycle
Measured: From randomization to close-out visit (12 weeks)
Change in weight
Body weight (kg)
Measured: 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
Measured: From randomization to close-out visit (12 weeks)
Change in blood hormone profile
Measured in clinical chemistry
Measured: 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
Measured: From randomization to close-out visit (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start4 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- de Seigneux Sophie
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, de Seigneux Sophie, University Hospital, Geneva
- Investigators
- Sophie de Seigneux, MD, PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618859
- Sponsor's protocol ID
- 2023-02172
- Other IDs
- 2023
- Acronym
- TRECK
- Status last verified
- May 2026
- First submitted
- 27 Sep 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria: A Pilot Randomized, Open-label, Double-arm Trial (TRECK)
- ClinicalTrials.gov ID
- NCT06618859
- Acronym / sponsor ID
- TRECK / 2023-02172
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- de Seigneux SophieUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating | Experimental | Behavioral: Time-restricted eating |
| Active control | Active comparator | Behavioral: Active control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical criteria
- Study-related criteria
Key exclusion criteria (18 listed)
- Clinical criteria
- Study-related criteria and other interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eatingAlso: TREParticipants 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. | Behavioural | Time-restricted eating |
| Active controlParticipants will be advised to keep the same eating rhythm and timing of meals per day during the intervention. | Behavioural | Active control |
Primary outcome
Change in urine albumin/creatinine ratio (UACR)
Time frame: From randomization to close-out visit (12 weeks)
Measured by 24h urine collection
15 secondary outcomes
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)
Change in lipid profile (concentration of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Time frame: From randomization to close-out visit (12 weeks)
Change in blood hormone profile
Time frame: From randomization to close-out visit (12 weeks)
Incidence of adverse events in response to the randomized intervention
Time frame: From randomization to close-out visit (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Related trials for Renal Insufficiency, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie de Seigneux, MD, PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating in people with Renal Insufficiency, Chronic, run by de Seigneux Sophie at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delal Dalga, MD, PhD (+41-22-3723311, delal.dalga@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine albumin/creatinine ratio (UACR) (time frame: From randomization to close-out visit (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.