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Dietary Intervention for Kidney Transplant Health
N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 18 and have received a kidney transplant.
Select...
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.
Select...
I have high blood pressure or am on medication for it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiometabolic health measures
Post-transplant complications rates
Secondary outcome measures
Dietary complications
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
914 Previous Clinical Trials
4,720,708 Total Patients Enrolled
Academy of Nutrition and DieteticsOTHER
24 Previous Clinical Trials
5,445 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a rejection episode before joining the study.I am over 18 and have received a kidney transplant.My kidney function is at a safe level for the trial.I have a history of high blood sugar or am on diabetes medication.You already follow a diet that consists only of plant-based foods.You are heavier than what is considered healthy for your height.I am unable to give consent by myself.You cannot see.I am 2 to 12 months post-transplant.I use a feeding tube or need special nutrition.This criterion means that you need to have at least one of the listed items to qualify.You are not willing to change your diet.I have high blood pressure or am on medication for it.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available for this research endeavor?
"Unfortunately, per clinicaltrials.gov this trial is not taking new patients at present. The study was originally published June 27th 2022 and most recently revised on November 15th 2022. Although the current study has concluded recruitment, there are 2485 other studies actively seeking participants right now."
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