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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
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.
UC San Diego
San Diego, California, United States
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.
Time frame: 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."
Time frame: 8 weeks
Cooking Class Adherence
Cooking class attendance will also be used as a measure of adherence.
Time frame: 8 weeks
Recruitment
Recruitment rate will be assessed by examining the number of potentially eligible participants, number contacted, consent rates, number completing the intervention.
Time frame: 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.
Time frame: 8 weeks
White blood cell count
Will be measured using standard methods.
Time frame: Change from baseline at 4 weeks and 8 weeks.
Absolute lymphocyte count
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Will be measured using standard methods.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (complete metabolic panel)
Will be measured using standard methods.
Time frame: Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (hemoglobin A1c)
Will be measured using standard methods.
Time frame: Change from baseline at 4 weeks and 8 weeks.
Biomarkers of cardiometabolic health (cholesterol and triglycerides)
Will be measured using standard methods.
Time frame: Change from baseline at 4 weeks and 8 weeks.
Concentration of vitamin B12
Will be measured using standard methods.
Time frame: Change from baseline at 4 and 8 weeks.
Concentration of vitamin B9
Will be measured using standard methods.
Time frame: Change from baseline at 4 and 8 weeks.
Concentration of iron
Will be measured using standard methods.
Time frame: Change from baseline at 4 and 8 weeks.
Concentration of ferritin
Will be measured using standard methods.
Time frame: 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.
Time frame: Change from baseline at 4 weeks and 8 weeks.