CKD AGE: Assessment of the Effect of Restriction on Alimentary AGE in Progression of Chronic Kidney Disease

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04827290

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic Chronic Kidney Disease stage3 Chronic Kidney Disease Stage 3B Chronic Kidney Disease Stage 3A (Disorder) Chronic Kidney Disease, Stage 3 (Moderate) Diet Habit	Behavioral: Low-AGE diet Behavioral: High-AGE diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Assessment of the Effect of Restriction on Alimentary AGE (Advanced Glycation Products) in Progression of Chronic Kidney Disease (CKD)

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal-protein and low-AGE through raw or rare proteins diet Normal-protein (0,8g/kg/day) and low-AGE through raw or rare proteins diet during 24 months	Behavioral: Low-AGE diet Low-AGE diet during 24 months
Active Comparator: Normal-protein and AGE-rich diet Normal-protein (0,8g/kg/day) and high-AGE through overcooked proteins diet during 24 months	Behavioral: High-AGE diet High-AGE diet during 24 months

Arm

Intervention/Treatment

Experimental: Normal-protein and low-AGE through raw or rare proteins diet

Normal-protein (0,8g/kg/day) and low-AGE through raw or rare proteins diet during 24 months

Behavioral: Low-AGE diet

Low-AGE diet during 24 months

Active Comparator: Normal-protein and AGE-rich diet

Normal-protein (0,8g/kg/day) and high-AGE through overcooked proteins diet during 24 months

Behavioral: High-AGE diet

High-AGE diet during 24 months

Outcome Measures

Primary Outcome Measures

Glomerular Filtration Rate [At 24 months]
Glomerular Filtration Rate estimated by the CKD-EPI formula with a blood sample

Secondary Outcome Measures

Proteinuria [At 24 months]
Proteinuria (g/24h) found in the 24-hour urine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with a grade IIIA-B CKD (GFR with CKD-EPI ≥ 30 mL/min and < 60mL/min)
Informed consent signed
Aged 18 to 89 years

Exclusion Criteria:

Protected adult
Acute renal failure
Patient already on a low-AGE diet (< 1kU AGE/day) following a dietetic consultation
Current participation in another interventional research