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

NCT04827290 | Not Yet Recruiting

• 1 other identifier: CKD AGE
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

kidney failure; advanced glycation products; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Glomerular Filtration Rate

  Glomerular Filtration Rate estimated by the CKD-EPI formula with a blood sample

  At 24 months

Secondary Outcomes (1)

• Proteinuria

  At 24 months

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: Low-AGE diet

Normal-protein and AGE-rich diet

ACTIVE COMPARATOR

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

Behavioral: High-AGE diet

Interventions

Low-AGE diet BEHAVIORAL

Low-AGE diet during 24 months

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

High-AGE diet BEHAVIORAL

High-AGE diet during 24 months

Normal-protein and AGE-rich diet

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead

Study Sites (1)

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Lymphoma, Follicular; Feeding Behavior; Renal Insufficiency

Condition Hierarchy (Ancestors)

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; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior, Animal; Behavior

Central Study Contacts

Fanny Doroszewski

CONTACT

0033478618398; fdoroszewski@chsjsl.fr

Gabrielle Normand, MD

CONTACT

lgnormand@chsjsl.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)