Autoimmune Protocol Diet Intervention on Proteinuria in IgA Nephropathy Patients

NCT07022574 | Not Yet Recruiting

• 1 other identifier: IRB# 25-0145
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study at UCLA Center for Health Sciences is testing whether the Autoimmune Protocol (AIP) diet can lower protein levels in the urine of people with IgA Nephropathy (IgAN), a common kidney disease that can lead to kidney failure. The AIP diet avoids foods that may cause inflammation (like dairy, grains, and sugar) for 8 weeks, then gradually reintroduces them over 4 months. We're enrolling 30 adults aged 18-65 with IgAN and protein in their urine to try this diet for 6 months. Participants will track their urine protein daily at home, keep a food log, and have monthly lab checkups, with support from a diet expert. The main goal is to see if the diet reduces urine protein by 20% or more, which could slow disease progression and reduce the need for treatments like dialysis. This exploratory study aims to find out if diet changes can help manage IgAN.

Conditions

IgA Nephropathy (IgAN)

Keywords

IgA Nephropathy; Kidney disease; Low inflammation diet; Autoimmune Protocol Diet; Protein in urine; Autoimmune Kidney Disease; Elimination diet; Diet and Kidney disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Urinary Protein to Creatine Ratio at 6months

  Primary Outcome Measure 1\. Change in Urinary Protein-to-Creatinine Ratio * Description: This measure assesses the reduction in proteinuria, a key indicator of IgA Nephropathy (IgAN) activity, following the Autoimmune Protocol (AIP) diet intervention. The urinary protein-to-creatinine ratio (UPCR) will be calculated from spot urine samples collected at baseline and monthly intervals. The study aims to detect a reduction of 20% or greater from baseline, reflecting a clinically meaningful improvement in kidney function. * Time Frame: Baseline to 6 months (end of study). * Measurement: Expressed as grams of protein per gram of creatinine (g/g), analyzed via laboratory testing of urine samples.

  6 months

Study Arms (1)

AIP Intervention arm

EXPERIMENTAL

Autoimmune Protocol Diet intervention

Behavioral: Low inflammation diet intervention

Interventions

Low inflammation diet intervention BEHAVIORAL

Autoimmune Protocol Diet intervention

Also known as: Autoimmune Protocol Diet

AIP Intervention arm

Eligibility Criteria

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

You may qualify if:

• Age 18-65
• Diagnosed with IgA Nephropathy (IgAN)
• Active disease with urine protein/creatinine ratio ≥ 1
• Stable ARB or ACE inhibitor for at least 1 month prior
• GFR \> 30
• Not on Budesonide 1 month prior or during study

You may not qualify if:

• Inability to comply with dietary or follow-up requirements
• Participation in other interventional studies
• Significant comorbidities interfering with study participation -

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Manhattan Beach, California, 90266, United States

Location

Related Publications (1)

• Konijeti GG, Kim N, Lewis JD, Groven S, Chandrasekaran A, Grandhe S, Diamant C, Singh E, Oliveira G, Wang X, Molparia B, Torkamani A. Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease. Inflamm Bowel Dis. 2017 Nov;23(11):2054-2060. doi: 10.1097/MIB.0000000000001221.

  PMID: 28858071 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, IGA; Kidney Diseases; Proteinuria

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thuy T Tran, MD

CONTACT

213-474-6452; tttran@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)