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Dietary Intervention to Improve Kidney Transplant Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05449496
Recruitment Status : Active, not recruiting
First Posted : July 8, 2022
Last Update Posted : July 11, 2022
Sponsor:
Collaborator:
Academy of Nutrition and Dietetics
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Kidney Diseases Transplant;Failure,Kidney Diabetes Hypertension Obesity Diet, Healthy Lifestyle, Healthy Behavioral: Dietary Education Curriculum Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Intervention to Improve Kidney Transplant Outcomes
Actual Study Start Date : June 27, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Experimental: Intervention Behavioral: Dietary Education Curriculum
Curriculum of dietary education and group-based counseling to encourage whole-food plant-based eating




Primary Outcome Measures :
  1. Cardiometabolic health measures [ Time Frame: 1 year ]
    Proportion of individuals achieving normotension, normoglycemia and weight reduction

  2. Post-transplant complications rates [ Time Frame: 1 year ]
    Composite incidence of emergency medical visits, hospitalizations and infections


Secondary Outcome Measures :
  1. Dietary complications [ Time Frame: 1 year ]
    Incidence of diarrhea, use of electrolyte correcting medications, severity of hyper- and hypoglycemic events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kidney transplant recipient aged 18 or greater
  • Post-transplant months 2-4
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05449496


Locations
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United States, California
UC Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Academy of Nutrition and Dietetics
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT05449496    
Other Study ID Numbers: 1771192
First Posted: July 8, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
diet
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Urologic Diseases