Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT06618859
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06618859
Study Brief:
Protocol Section:
NCT06618859