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

NCT06618859 | Recruiting

• 1 other identifier: 2023-02172
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• Change in urine albumin/creatinine ratio (UACR)

  Measured by 24h urine collection

  From randomization to close-out visit (12 weeks)

Secondary Outcomes (15)

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

  From randomization to close-out visit (12 weeks)

• Change in blood pressure

  From randomization to close-out visit (12 weeks)

• Change in systolic and diastolic blood pressure

  From randomization to close-out visit (12 weeks)

• Change in body fat mass and regional distribution

  From randomization to close-out visit (12 weeks)

• Change in body fat mass

  From randomization to close-out visit (12 weeks)

Study Arms (2)

Time-restricted eating

EXPERIMENTAL

Behavioral: Time-restricted eating

Active control

ACTIVE COMPARATOR

Behavioral: Active control

Interventions

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.

Also known as: TRE

Time-restricted eating

Active control BEHAVIORAL

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

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• de Seigneux Sophie: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospital, Geneva

Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Sophie de Seigneux, MD, PhD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delal Dalga, MD, PhD

CONTACT

+41-22-3723311; delal.dalga@unige.ch

Anna Faivre, MD, PhD

CONTACT

+41-79-5534361; anna.faivre@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CH (1)