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Dietary Intervention for Kidney Transplant Health

N/A
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Kidney transplant recipient aged 18 or greater
eGFR >= 20 mL/min
Must not have
Unable to consent
Gastrointestinal feeding tube or requires alternative nutrition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial found that teaching kidney transplant recipients to eat a whole-food plant-based diet improved their health outcomes compared to the standard of care.

Who is the study for?
This trial is for kidney transplant recipients aged 18 or older, with a history of high blood sugar or diabetes, overweight status (BMI >= 25), and within 2-12 months post-transplant. They should have an eGFR >= 20 mL/min and may also have high blood pressure. It's not for those already on plant-based diets, unable to consent, prisoners, with recent organ rejection, GI feeding tubes, language barriers regarding English, visual impairment or unwillingness to change diet.
What is being tested?
The study tests a dietary education program that teaches patients how to follow a whole-food plant-based diet versus the standard care given after kidney transplantation. Participants are randomly assigned to one of these two groups shortly after their transplant surgery.
What are the potential side effects?
Since this trial involves dietary changes rather than medication or invasive procedures, side effects might include digestive adjustments as the body adapts to new eating habits but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and have received a kidney transplant.
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My kidney function is at a safe level for the trial.
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I have a history of high blood sugar or am on diabetes medication.
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I have high blood pressure or am on medication for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent by myself.
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I use a feeding tube or need special nutrition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cardiometabolic health measures
Post-transplant complications rates
Secondary study objectives
Dietary complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,756,010 Total Patients Enrolled
Academy of Nutrition and DieteticsOTHER
24 Previous Clinical Trials
5,445 Total Patients Enrolled

Media Library

Whole-Food Plant-Based Dietary Pattern (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05449496 — N/A
Kidney Disease Research Study Groups: Intervention, Control
Kidney Disease Clinical Trial 2023: Whole-Food Plant-Based Dietary Pattern Highlights & Side Effects. Trial Name: NCT05449496 — N/A
Whole-Food Plant-Based Dietary Pattern (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05449496 — N/A
~0 spots leftby Dec 2024
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