Chronic Lymphocytic Leukemia Stage A(0)NCT06377501
Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)
A study testing Whole-food, plant-based diet in people with Chronic Lymphocytic Leukemia Stage A(0), run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia Stage A(0)
- What is being tested?
- Whole-food, plant-based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Lymphocytic Leukemia Stage A(0)
- Being tested
- Whole-food, plant-based diet
- Keywords
- whole-food plant-based diet, CLL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-food, plant-based dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Whole-food, plant-based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: 8 weeks
Cooking Class Adherence
Cooking class attendance will also be used as a measure of adherence.
Measured: 8 weeks
Recruitment
Recruitment rate will be assessed by examining the number of potentially eligible participants, number contacted, consent rates, number completing the intervention.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (12)
White blood cell count
Will be measured using standard methods.
Measured: Change from baseline at 4 weeks and 8 weeks.
Absolute lymphocyte count
Will be measured using standard methods.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (complete metabolic panel)
Will be measured using standard methods.
Measured: Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (hemoglobin A1c)
Will be measured using standard methods.
Measured: Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (cholesterol and triglycerides)
Will be measured using standard methods.
Measured: Change from baseline at 4 weeks and 8 weeks.
Concentration of vitamin B12
Will be measured using standard methods.
Measured: Change from baseline at 4 and 8 weeks.
Concentration of vitamin B9
Will be measured using standard methods.
Measured: Change from baseline at 4 and 8 weeks.
Concentration of iron
Will be measured using standard methods.
Measured: Change from baseline at 4 and 8 weeks.
Concentration of ferritin
Will be measured using standard methods.
Measured: 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.
Measured: Change from baseline at 4 weeks and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start7 Mar 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia Stage A(0)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariel Portera, University of California, San Diego
- Investigators
- Ariel Portera, DO, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377501
- Sponsor's protocol ID
- 804687
- Status last verified
- Aug 2025
- First submitted
- 5 Apr 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Whole-Food, Plant-Based Dietary Intervention for Patients With Low-Risk Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT06377501
- Acronym / sponsor ID
- 804687
- Conditions
- Chronic Lymphocytic Leukemia Stage A(0)
- Keywords
- whole-food plant-based diet, CLL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Whole-food, plant-based dietSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-food, plant-based dietSubjects 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 | Intervention Group |
Primary outcome
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.
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."
Cooking Class Adherence
Time frame: 8 weeks
Cooking class attendance will also be used as a measure of adherence.
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.
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.
12 secondary outcomes
White blood cell count
Time frame: Change from baseline at 4 weeks and 8 weeks.
Absolute lymphocyte count
Time frame: 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.
Anthropometric Measures (waist circumference)
Time frame: 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.
Biomarkers of cardiometabolic health (hemoglobin A1c)
Time frame: 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.
Concentration of vitamin B12
Time frame: Change from baseline at 4 and 8 weeks.
Concentration of vitamin B9
Time frame: Change from baseline at 4 and 8 weeks.
Concentration of iron
Time frame: Change from baseline at 4 and 8 weeks.
Concentration of ferritin
Time frame: Change from baseline at 4 and 8 weeks.
Blood pressure
Time frame: Change from baseline at 4 weeks and 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Portera, DO principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-food, plant-based diet in people with Chronic Lymphocytic Leukemia Stage A(0), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Dietary Intervention (time frame: Up to 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.