Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria (NCT06618859) | Clinical Trial Compass
RecruitingNot Applicable
Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria
Switzerland50 participantsStarted 2024-12-04
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \> 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in urine albumin/creatinine ratio (UACR)
Timeframe: From randomization to close-out visit (12 weeks)