Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)

Feasibility of a Whole-Food, Plant-Based Dietary Intervention for Patients With Low-Risk Chronic Lymphocytic Leukemia

This study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk CLL who are undergoing observation. Over the course of 8 weeks, participants will attend weekly group cooking classes via Zoom lead by a RD. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention.

Study Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukemia Stage A(0)
• Intervention / Treatment: Other: Whole-food, plant-based diet

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • UC San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have a diagnosis of low-risk CLL according to the modified Rai staging criteria for a minimum of 12 months and are currently undergoing observation.
• Access to a computer or tablet and Zoom.

Exclusion Criteria:

• Have active disease and are currently receiving pharmacologic treatment for CLL
• Have previously received treatment for CLL
• Are currently following a vegan or vegetarian diet
• A previous or current diagnosis of disordered eating including anorexia, bulimia, binge eating disorder or avoidant/restrictive food intake disorder.
• A diagnosis of Type 1 diabetes
• A diagnosis of Insulin dependent type 2 diabetes
• Currently pregnant or planning to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Subjects will be instructed to adopt a whole-food, plant-based diet for 8 weeks. They will attend weekly group cooking classes led by a RD and receive weekly health coaching sessions.	Other: Whole-food, plant-based diet; Subjects will be instructed to adopt a whole-food, plant-based diet for 8 weeks. They will attend weekly group cooking classes led by a RD and receive weekly health coaching sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the Dietary Intervention	Adherence to the dietary intervention will be calculated using a dietary index developed specifically for this diet. Dietary adherence scores will be calculated using a pre- and post-intervention food frequency questionnaire, as well as 3-day food diaries obtained throughout the intervention.	Up to 24 weeks
Satisfaction with the Dietary Intervention	Subject satisfaction will be assessed post-intervention using an acceptability, appropriateness and feasibility questionnaire. The questionnaire does not use a scoring system, rather statements will be provided and participants will provide an answer ranging from "completely disagree" to "completely agree."	8 weeks
Cooking Class Adherence	Cooking class attendance will also be used as a measure of adherence.	8 weeks
Recruitment	Recruitment rate will be assessed by examining the number of potentially eligible participants, number contacted, consent rates, number completing the intervention.	Through study completion, an average of 1 year
Retention	Retention will be calculated using the number of participants who enroll in the study and the number of participants who complete the 8 week intervention.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White blood cell count	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Absolute lymphocyte count	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Anthropometric Measures (height, weight, body mass index)	Will be measured using standard methods. Weight and height will be combined to report BMI in kg/m^2.	Change from baseline at 4 weeks and 8 weeks.
Anthropometric Measures (waist circumference)	Will be measured using standard methods. Weight and height will be combined to report BMI in kg/m^2.	Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (complete metabolic panel)	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (hemoglobin A1c)	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (cholesterol and triglycerides)	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Concentration of vitamin B12	Will be measured using standard methods.	Change from baseline at 4 and 8 weeks.
Concentration of vitamin B9	Will be measured using standard methods.	Change from baseline at 4 and 8 weeks.
Concentration of iron	Will be measured using standard methods.	Change from baseline at 4 and 8 weeks.
Concentration of ferritin	Will be measured using standard methods.	Change from baseline at 4 and 8 weeks.
Blood pressure	Will be measured using standard methods, both systolic and diastolic blood pressure will be assessed.	Change from baseline at 4 weeks and 8 weeks.

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Ariel Portera, DO, UC San Diego

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: CLL; whole-food plant-based diet
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Hematologic Diseases; Leukemia, B-Cell; Chronic Disease; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, Plant-Based
• Other Study ID Numbers: 804687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No