Autoimmune Protocol Diet Intervention on Proteinuria in IgA Nephropathy Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to comply with dietary or follow-up requirements

Participation in other interventional studies

Significant comorbidities interfering with study participation -

Trial design

Design model

Single group

Treatments tested in this trial

  • Low inflammation diet intervention

    Behavioral

    Autoimmune Protocol Diet intervention

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: AIP Intervention armExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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