Chronic Lymphocytic Leukemia Stage A(0)
Conditions
Keywords
whole-food plant-based diet, CLL
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.
Interventions
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.
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Cooking Class Adherence | 8 weeks | Cooking class attendance will also be used as a measure of adherence. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 B12 | Change from baseline at 4 and 8 weeks. | Will be measured using standard methods. |
| White blood cell count | Change from baseline at 4 weeks 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. |
| 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. |
| Concentration of vitamin B9 | 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. |
| 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. |
| Biomarkers of cardiometabolic health (complete metabolic panel) | Change from baseline at 4 weeks and 8 weeks. | Will be measured using standard methods. |
Countries
United States
Outcome results
None listed