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Trial Title:
Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)
NCT ID:
NCT06377501
Condition:
Chronic Lymphocytic Leukemia Stage A(0)
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Conditions: Keywords:
whole-food plant-based diet
CLL
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Whole-food, plant-based diet
Description:
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.
Arm group label:
Intervention Group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UC San Diego
Address:
City:
San Diego
Zip:
92093
Country:
United States
Start date:
March 7, 2023
Completion date:
July 2024
Lead sponsor:
Agency:
University of California, San Diego
Agency class:
Other
Source:
University of California, San Diego
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06377501
