Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia Stage A(0) Clinical Trial

Official title:

Feasibility of a Whole-Food, Plant-Based Dietary Intervention for Patients With Low-Risk Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06377501
• Other study ID #: 804687
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: July 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia Stage A(0)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	UC San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cooking Class Adherence	Cooking class attendance will also be used as a measure of adherence.	8 weeks
Primary	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
Primary	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
Secondary	White blood cell count	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Secondary	Absolute lymphocyte count	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Secondary	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.
Secondary	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.
Secondary	Biomarkers of cardiometabolic health (complete metabolic panel)	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Secondary	Biomarkers of cardiometabolic health (hemoglobin A1c)	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Secondary	Biomarkers of cardiometabolic health (cholesterol and triglycerides)	Will be measured using standard methods.	Change from baseline at 4 weeks and 8 weeks.
Secondary	Concentration of vitamin B12	Will be measured using standard methods.	Change from baseline at 4 and 8 weeks.
Secondary	Concentration of vitamin B9	Will be measured using standard methods.	Change from baseline at 4 and 8 weeks.
Secondary	Concentration of iron	Will be measured using standard methods.	Change from baseline at 4 and 8 weeks.
Secondary	Concentration of ferritin	Will be measured using standard methods.	Change from baseline at 4 and 8 weeks.
Secondary	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.