Clinical trial NCT06377501: Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)
Official title: Feasibility of a Whole-Food, Plant-Based Dietary Intervention for Patients With Low-Risk Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Lymphocytic Leukemia Stage A(0)
Keywords: whole-food plant-based diet
CLL
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence to the Dietary Intervention
timeFrame: Up to 24 weeks
measure: Satisfaction with the Dietary Intervention
timeFrame: 8 weeks
measure: Cooking Class Adherence
timeFrame: 8 weeks
measure: Recruitment
timeFrame: Through study completion, an average of 1 year
measure: Retention
timeFrame: 8 weeks
Secondary outcomes:
measure: White blood cell count
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Absolute lymphocyte count
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Anthropometric Measures (height, weight, body mass index)
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Anthropometric Measures (waist circumference)
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Biomarkers of cardiometabolic health (complete metabolic panel)
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Biomarkers of cardiometabolic health (hemoglobin A1c)
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Biomarkers of cardiometabolic health (cholesterol and triglycerides)
timeFrame: Change from baseline at 4 weeks and 8 weeks.
measure: Concentration of vitamin B12
timeFrame: Change from baseline at 4 and 8 weeks.
measure: Concentration of vitamin B9
timeFrame: Change from baseline at 4 and 8 weeks.
measure: Concentration of iron
timeFrame: Change from baseline at 4 and 8 weeks.
measure: Concentration of ferritin
timeFrame: Change from baseline at 4 and 8 weeks.
measure: Blood pressure
timeFrame: Change from baseline at 4 weeks and 8 weeks.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: UC San Diego
name: Ariel Portera, DO
role: PRINCIPAL_INVESTIGATOR
References: