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Behavioral Intervention

Plant-based Diet for Kidney Transplant Recipients

N/A
Recruiting
Led By Muralidharan Jagadeesan, MD
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estimated glomerular filtration rate > 45ml/min/1.73 m^2
Without evidence of active infection or inflammatory conditions
Must not have
History of malignancy
Advanced heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 10, 18, 26
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see how switching kidney transplant recipients to a plant-based diet affects their heart and metabolic health, as well as inflammation levels. Participants will follow a plant-based diet for at least 16

Who is the study for?
This trial is for kidney transplant recipients who are more than 3 months post-transplant, on stable immunosuppressive medication, speak English, have reliable internet access, and a kidney function (eGFR) over 45 ml/min/1.73 m^2 without active infections or inflammatory conditions.
What is being tested?
The study tests how a plant-based diet affects heart health markers and inflammation in people who've had a kidney transplant. Participants will switch to this diet for at least 16 weeks with support from the research team and provide blood, urine, fecal samples as well as complete health questionnaires.
What are the potential side effects?
While not typical with dietary changes like adopting a plant-based diet, possible side effects may include gastrointestinal discomfort such as bloating or gas during the adjustment period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good.
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I do not have any ongoing infections or inflammation.
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I had a kidney transplant more than 3 months ago.
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I am on a stable dose of medication to suppress my immune system.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer before.
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My condition is advanced heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 10, 18, 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 10, 18, 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anthropometry
BMI
Blood pressure
+9 more
Secondary study objectives
Changes in gut microbiome
Creatinine
Estimated glomerular filtration rate
+4 more
Other study objectives
Blood electrolytes (Na, K, Cl, Ca, Phosphorous)
Urine albumin
Urine electrolytes (Na, K, Cl, Ca, Phosphorous)
+1 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Plant-based dietExperimental Treatment1 Intervention
The group will follow a plant-based diet. Compliance will be checked with dietary questionnaires.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plant-based diet
2021
N/A
~360

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor
252 Previous Clinical Trials
461,125 Total Patients Enrolled
2 Trials studying Kidney Failure
155 Patients Enrolled for Kidney Failure
Muralidharan Jagadeesan, MDPrincipal InvestigatorGeorge Washington University
~15 spots leftby Nov 2025
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