UC San Diego
San Diego, California, 92093, United States
Completed
NCT Number: NCT06377501
Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Whole-food, plant-based diet
OtherSubjects 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.
Primary outcomes
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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.
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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.
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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.
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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.
Secondary outcomes
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White blood cell count
Time frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
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Absolute lymphocyte count
Time frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
-
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.
-
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.
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Biomarkers of cardiometabolic health (complete metabolic panel)
Time frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
-
Biomarkers of cardiometabolic health (hemoglobin A1c)
Time frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
-
Biomarkers of cardiometabolic health (cholesterol and triglycerides)
Time frame: Change from baseline at 4 weeks and 8 weeks.
Will be measured using standard methods.
-
Concentration of vitamin B12
Time frame: Change from baseline at 4 and 8 weeks.
Will be measured using standard methods.
-
Concentration of vitamin B9
Time frame: Change from baseline at 4 and 8 weeks.
Will be measured using standard methods.
-
Concentration of iron
Time frame: Change from baseline at 4 and 8 weeks.
Will be measured using standard methods.
-
Concentration of ferritin
Time frame: Change from baseline at 4 and 8 weeks.
Will be measured using standard methods.
-
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.
Sponsors and collaborators
Lead sponsor
University of California, San Diego
Other
Registry information
Official study title
Feasibility of a Whole-Food, Plant-Based Dietary Intervention for Patients With Low-Risk Chronic Lymphocytic Leukemia
Important dates
- Study start
- 2023
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Apr 22, 2024
- Registry last updated
- Sep 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.