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Dietary Intervention to Improve Kidney Transplant Outcomes

Primary Purpose

Kidney Transplant; Complications, Kidney Diseases, Transplant;Failure,Kidney

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Education Curriculum
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplant; Complications focused on measuring diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Kidney transplant recipient aged 18 or greater
  • Post-transplant months 2-12
  • eGFR >= 20 mL/min
  • Have at least one of the following:

    1. Hypertension history (BP >= 150/90 or on BP medications)
    2. Hyperglycemia history (FBG >= 100 x 2 or on diabetes medications)
    3. Overweight (BMI >= 25)

Exclusion Criteria:

  • Rejection episode before study enrollment
  • Gastrointestinal feeding tube or requires alternative nutrition
  • Unable to understand or read English
  • Unable to attend online classes or complete study questionnaires independently
  • Already eating a plant-based diet
  • Unwilling to make dietary changes
  • Pregnant or breastfeeding
  • Unable to consent
  • Blindness
  • Prisoners

Sites / Locations

  • UC Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Cardiometabolic health measures
Proportion of individuals achieving normotension, normoglycemia and weight reduction
Post-transplant complications rates
Composite incidence of emergency medical visits, hospitalizations and infections

Secondary Outcome Measures

Dietary complications
Incidence of diarrhea, use of electrolyte correcting medications, severity of hyper- and hypoglycemic events

Full Information

First Posted
July 5, 2022
Last Updated
June 13, 2023
Sponsor
University of California, Davis
Collaborators
Academy of Nutrition and Dietetics
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1. Study Identification

Unique Protocol Identification Number
NCT05449496
Brief Title
Dietary Intervention to Improve Kidney Transplant Outcomes
Official Title
Dietary Intervention to Improve Kidney Transplant Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Academy of Nutrition and Dietetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant
Detailed Description
A whole-food plant-based dietary pattern has emerged as fundamental in preventing and treating many of the lifestyle-related diseases of Western medicine, including cardiovascular disease, diabetes, hyperlipidemia, obesity, hypertension, chronic kidney disease and certain cancers. These diseases often occur or recur in the post-transplant population, leading to patient and graft loss. However, dietary education for kidney transplant recipients is not standardized and many patients remain ignorant about optimum healthy dietary practices. These patients are further challenged by the common occurrence of electrolyte derangements that require dietary restrictions. We propose a randomized controlled trial of a dietary intervention that focuses on whole-food plant-based eating in the kidney transplant population, testing this dietary pattern's impact on recipient health outcomes. This study addresses the critical need for cost-effective and safe strategies to improve health outcomes in transplant recipients and preserve kidney graft function. We have assembled an interdisciplinary team with expertise in transplant nephrology, lifestyle medicine, plant-based renal nutrition, health coaching and biostatistics to investigate the following aims: (1) to test the efficacy of a whole-food plant-based diet on improving kidney recipient cardiovascular and metabolic health and kidney allograft function, (2) to test the effect of a whole-food plant-based diet on kidney recipient post-transplant complication rates, and (3) to test the feasibility of a dietary education program on kidney transplant recipients' ability to adhere to a whole-food plant-based diet, all within a 12-month randomized controlled trial of plant-based diet versus usual care. Dietary counseling will focus on eating a predominantly plant-based diet comprised of fruits, vegetables, whole grains and legumes, and low in animal products, fats and processed foods. Dietary counseling will occur in group-based sessions weekly for the first month, then biweekly for 5 months. Patients will be followed for 12 months. This study has the potential to establish dietary intervention as a way to prolong kidney graft survival and to improve overall health and survival in kidney transplant recipients. This study will also launch a cohort of patients whose dietary patterns can be followed and compared over time, providing groundwork for further research into the connections between diet and kidney-related outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant; Complications, Kidney Diseases, Transplant;Failure,Kidney, Diabetes, Hypertension, Obesity, Diet, Healthy, Lifestyle, Healthy
Keywords
diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Dietary Education Curriculum
Intervention Description
Curriculum of dietary education and group-based counseling to encourage whole-food plant-based eating
Primary Outcome Measure Information:
Title
Cardiometabolic health measures
Description
Proportion of individuals achieving normotension, normoglycemia and weight reduction
Time Frame
1 year
Title
Post-transplant complications rates
Description
Composite incidence of emergency medical visits, hospitalizations and infections
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Dietary complications
Description
Incidence of diarrhea, use of electrolyte correcting medications, severity of hyper- and hypoglycemic events
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Kidney transplant recipient aged 18 or greater Post-transplant months 2-12 eGFR >= 20 mL/min Have at least one of the following: Hypertension history (BP >= 150/90 or on BP medications) Hyperglycemia history (FBG >= 100 x 2 or on diabetes medications) Overweight (BMI >= 25) Exclusion Criteria: Rejection episode before study enrollment Gastrointestinal feeding tube or requires alternative nutrition Unable to understand or read English Unable to attend online classes or complete study questionnaires independently Already eating a plant-based diet Unwilling to make dietary changes Pregnant or breastfeeding Unable to consent Blindness Prisoners
Facility Information:
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dietary Intervention to Improve Kidney Transplant Outcomes

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