Dietary Intervention to Improve Kidney Transplant Outcomes

NCT05449496 | Active Not Recruiting

• 1 other identifier: 1771192
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

diet

Outcome Measures

Primary Outcomes (2)

• Cardiometabolic health measures

  Proportion of individuals achieving normotension, normoglycemia and weight reduction

  1 year

• Post-transplant complications rates

  Composite incidence of emergency medical visits, hospitalizations and infections

  1 year

Secondary Outcomes (1)

• Dietary complications

  1 year

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

Behavioral: Dietary Education Curriculum

Interventions

Dietary Education Curriculum BEHAVIORAL

Curriculum of dietary education and group-based counseling to encourage whole-food plant-based eating

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Academy of Nutrition and Dietetics: collaborator

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Diabetes Mellitus; Hypertension; Obesity

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 8, 2022
• Study Start: June 27, 2022
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)