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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-food, plant-based diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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." | 8 weeks |
| Cooking Class Adherence | Cooking class attendance will also be used as a measure of adherence. | 8 weeks |
| Recruitment | Recruitment rate will be assessed by examining the number of potentially eligible participants, number contacted, consent rates, number completing the intervention. | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| White blood cell count | Will be measured using standard methods. | Change from baseline at 4 weeks and 8 weeks. |
| Absolute lymphocyte count | Will be measured using standard methods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel Portera, DO | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | San Diego | California | 92093 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2023 | Apr 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| 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. | 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. | Change from baseline at 4 weeks and 8 weeks. |
| Biomarkers of cardiometabolic health (complete metabolic panel) | Will be measured using standard methods. | Change from baseline at 4 weeks and 8 weeks. |
| Biomarkers of cardiometabolic health (hemoglobin A1c) | Will be measured using standard methods. | Change from baseline at 4 weeks and 8 weeks. |
| Biomarkers of cardiometabolic health (cholesterol and triglycerides) | Will be measured using standard methods. | Change from baseline at 4 weeks and 8 weeks. |
| Concentration of vitamin B12 | Will be measured using standard methods. | Change from baseline at 4 and 8 weeks. |
| Concentration of vitamin B9 | Will be measured using standard methods. | Change from baseline at 4 and 8 weeks. |
| Concentration of iron | Will be measured using standard methods. | Change from baseline at 4 and 8 weeks. |
| Concentration of ferritin | Will be measured using standard methods. | 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. | Change from baseline at 4 weeks and 8 weeks. |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |