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

NCT06377501 | Completed

• 1 other identifier: 804687
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia Stage A(0)

Keywords

whole-food plant-based diet; CLL

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (12)

• White blood cell count

  Change from baseline at 4 weeks and 8 weeks.

• Absolute lymphocyte count

  Change from baseline at 4 weeks and 8 weeks.

• Anthropometric Measures (height, weight, body mass index)

  Change from baseline at 4 weeks and 8 weeks.

• Anthropometric Measures (waist circumference)

  Change from baseline at 4 weeks and 8 weeks.

• Biomarkers of cardiometabolic health (complete metabolic panel)

  Change from baseline at 4 weeks and 8 weeks.

Study Arms (1)

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.

Other: Whole-food, plant-based diet

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Interventions

Diet, Plant-Based

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ariel Portera, DO

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Family Medicine

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 22, 2024
• Study Start: March 7, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)