Autoimmune Protocol Diet for IgA Nephropathy

Overseen By Thuy T Tran, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: ARB, ACE inhibitors

Must not be taking: Budesonide

Disqualifiers: Other studies, Significant comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Autoimmune Protocol (AIP) diet can benefit individuals with IgA Nephropathy (IgAN), a kidney disease that can lead to kidney failure. The diet eliminates foods believed to cause inflammation, such as dairy and grains, and then gradually reintroduces them. Researchers aim to determine if this diet can lower protein levels in urine, potentially slowing disease progression and reducing the need for treatments like dialysis. The trial seeks participants diagnosed with IgAN who have high protein levels in their urine and are stable on certain medications. Participants will follow the diet for six months and track their progress with support from a diet expert. As an unphased trial, this study offers a unique opportunity to explore a dietary approach to managing IgAN symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have been on a stable ARB or ACE inhibitor for at least 1 month before joining. You cannot be on Budesonide 1 month prior or during the study.

What prior data suggests that this diet is safe for people with IgA Nephropathy?

Research has shown that the Autoimmune Protocol (AIP) diet is generally easy to follow. This diet involves avoiding certain foods that might cause inflammation, such as dairy, grains, and sugar, which are gradually reintroduced over time. Although specific data on the AIP diet's side effects for individuals with IgA Nephropathy (IgAN) is lacking, it resembles other anti-inflammatory diets that many have used safely.

This study is exploratory and not part of a specific phase of drug testing, so no serious safety issues from the diet itself are expected. Participants will receive regular checkups to address any unexpected problems promptly. Overall, the AIP diet is considered a safe way to explore managing IgAN by potentially reducing inflammation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Autoimmune Protocol (AIP) Diet is unique because it focuses on using dietary changes to potentially manage IgA Nephropathy, a kidney condition often treated with medications like corticosteroids and immunosuppressants. Unlike these standard treatments, which can have significant side effects, the AIP Diet emphasizes eliminating foods that may trigger immune responses and incorporating nutrient-dense foods to support overall health. Researchers are excited about this approach because it offers a non-pharmacological option that might reduce symptoms and improve quality of life without the side effects associated with traditional medications.

What evidence suggests that the Autoimmune Protocol Diet is effective for IgA Nephropathy?

Research has shown that the Autoimmune Protocol (AIP) Diet might help lower protein levels in the urine of people with IgA Nephropathy (IgAN). This trial will evaluate the AIP Diet intervention, which involves avoiding foods that could cause inflammation, such as dairy, grains, and sugar. The aim is to determine if this dietary change can reduce urine protein by 20% or more. Lowering protein in the urine is important because it might slow kidney damage and reduce the need for treatments like dialysis. Although direct evidence about the diet's effect on IgAN is limited, early studies suggest it could help with conditions related to inflammation. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18-65 with IgA Nephropathy, a kidney condition causing protein in the urine, can join this study. They should be willing to follow a strict diet and track their health for 6 months. People who don't meet these criteria or have other health issues that could interfere with the diet's effects won't be eligible.

Inclusion Criteria

I am between 18 and 65 years old.

Active disease with urine protein/creatinine ratio ≥ 1

My kidney function is normal or only mildly reduced.

Exclusion Criteria

Participation in other interventional studies

Significant comorbidities interfering with study participation

Inability to comply with dietary or follow-up requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Elimination Phase

Participants follow the AIP diet, eliminating foods known to provoke inflammation for 8 weeks

8 weeks

2 visits (in-person), weekly virtual check-ins

Reintroduction Phase

Participants gradually reintroduce foods over 4 months to assess individual tolerances and impact on renal markers

16 weeks

4 visits (in-person), monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Autoimmune Protocol Diet

Trial Overview The trial is testing if an Autoimmune Protocol Diet, which cuts out potentially inflammatory foods like dairy, grains, and sugar for 8 weeks before reintroducing them slowly over 4 months, can reduce proteinuria in IgA Nephropathy patients by at least 20%.

How Is the Trial Designed?

Group I: AIP Intervention arm Experimental Treatment 1 Intervention

Autoimmune Protocol Diet intervention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07022574

Autoimmune Protocol Diet Intervention on Proteinuria in ... 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 ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538214/

IgA Nephropathy (Berger Disease) - StatPearls - NCBI Bookshelf Immunoglobulin A (IgA) nephropathy, or IgAN, also known as Berger disease, is one of the leading causes of glomerulonephritis and renal failure.

3. withpower.com withpower.com/trial/phase-glomerulonephritis-iga-1-2026-838b9

Autoimmune Protocol Diet for IgA Nephropathy 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.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0323530

Clinical study outcomes in IgA nephropathy: A systematic ... This systematic literature review identifies, collates, summarizes, and assesses the quality of clinical trial data describing the efficacy of therapies used ...

5. ajkd.org ajkd.org/article/S0272-6386(23)00831-4/fulltext

The Treatment of Primary IgA Nephropathy: Change ... We suggest a present-day approach to treatment of individuals with IgAN, expose the limitations in our knowledge, and discuss new treatments that may arise.

6. igan.org igan.org/diet-nutrition/managing-iga-nephropathy-with-an-anti-inflammatory-diet/

Managing IgA Nephropathy with an Anti-inflammatory Diet This article reviews the anti-inflammatory diet principles and IgAN. Understanding IgA Nephropathy. IgA Nephropathy (IgAN) is a rare auto-immune kidney disease.

7. kidney.org kidney.org/kidney-topics/iga-nephropathy

IgA Nephropathy (IgAN) IgA nephropathy (IgAN) is a type of kidney disease where antibodies build up in your kidneys and cause damage to your glomeruli (small filters inside your ...

8. renalandurologynews.com renalandurologynews.com/features/kdigo-iga-nephropathy-guideline/

KDIGO's New IgA Nephropathy Guideline Is Paradigm- ... Patients with proteinuria of 0.5 g/d or more are at risk for IgAN progression and should receive active treatment. A major update from the new ...