Dietary Intervention to Improve Kidney Transplant Outcomes

Obesity Clinical Trial

Official title:

Dietary Intervention to Improve Kidney Transplant Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05449496
• Other study ID #: 1771192
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diet, Healthy
• Hypertension
• Kidney Diseases
• Kidney Transplant; Complications
• Lifestyle, Healthy
• Obesity
• Renal Insufficiency
• Transplant;Failure,Kidney

Intervention

Behavioral:
• Dietary Education Curriculum
Curriculum of dietary education and group-based counseling to encourage whole-food plant-based eating

Locations

Country	Name	City	State
United States	UC Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Academy of Nutrition and Dietetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiometabolic health measures	Proportion of individuals achieving normotension, normoglycemia and weight reduction	1 year
Primary	Post-transplant complications rates	Composite incidence of emergency medical visits, hospitalizations and infections	1 year
Secondary	Dietary complications	Incidence of diarrhea, use of electrolyte correcting medications, severity of hyper- and hypoglycemic events	1 year