Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Chronic Lymphocytic Leukemia Stage A(0)
- Interventions
- Other: Whole-food, plant-based diet
- Registration Number
- NCT06377501
- Lead Sponsor
- University of California, San Diego
- Brief 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. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 19
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Group 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.
- Primary Outcome Measures
Name Time Method Satisfaction with the Dietary Intervention 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."
Recruitment 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.
Adherence to the Dietary Intervention 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.
Cooking Class Adherence 8 weeks Cooking class attendance will also be used as a measure of adherence.
Retention 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 Outcome Measures
Name Time Method Biomarkers of cardiometabolic health (complete metabolic panel) Change from baseline at 4 weeks and 8 weeks. Will be measured using standard methods.
Anthropometric Measures (height, weight, body mass index) 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) 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.
Blood pressure Change from baseline at 4 weeks and 8 weeks. Will be measured using standard methods, both systolic and diastolic blood pressure will be assessed.
White blood cell count Change from baseline at 4 weeks and 8 weeks. Will be measured using standard methods.
Concentration of vitamin B12 Change from baseline at 4 and 8 weeks. Will be measured using standard methods.
Absolute lymphocyte count Change from baseline at 4 weeks and 8 weeks. Will be measured using standard methods.
Biomarkers of cardiometabolic health (hemoglobin A1c) Change from baseline at 4 weeks and 8 weeks. Will be measured using standard methods.
Biomarkers of cardiometabolic health (cholesterol and triglycerides) Change from baseline at 4 weeks and 8 weeks. Will be measured using standard methods.
Concentration of vitamin B9 Change from baseline at 4 and 8 weeks. Will be measured using standard methods.
Concentration of iron Change from baseline at 4 and 8 weeks. Will be measured using standard methods.
Concentration of ferritin Change from baseline at 4 and 8 weeks. Will be measured using standard methods.
Trial Locations
- Locations (1)
UC San Diego
🇺🇸San Diego, California, United States