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

August 29, 2025 updated by: Ariel Portera, University of California, San Diego

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence to the Dietary Intervention
Time Frame: Up to 24 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Cooking class attendance will also be used as a measure of adherence.
8 weeks
Recruitment
Time Frame: Through study completion, an average of 1 year
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
Time Frame: 8 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
White blood cell count
Time Frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 weeks and 8 weeks.
Absolute lymphocyte count
Time Frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 weeks and 8 weeks.
Anthropometric Measures (height, weight, body mass index)
Time Frame: Change from baseline at 4 weeks and 8 weeks.
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)
Time Frame: Change from baseline at 4 weeks and 8 weeks.
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)
Time Frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (hemoglobin A1c)
Time Frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (cholesterol and triglycerides)
Time Frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 weeks and 8 weeks.
Concentration of vitamin B12
Time Frame: Change from baseline at 4 and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 and 8 weeks.
Concentration of vitamin B9
Time Frame: Change from baseline at 4 and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 and 8 weeks.
Concentration of iron
Time Frame: Change from baseline at 4 and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 and 8 weeks.
Concentration of ferritin
Time Frame: Change from baseline at 4 and 8 weeks.
Will be measured using standard methods.
Change from baseline at 4 and 8 weeks.
Blood pressure
Time Frame: Change from baseline at 4 weeks and 8 weeks.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ariel Portera, DO, UC San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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