CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLL
NCT07487428
Summary
The goal of this clinical trial is to investigate whether a short-term (4-week) whole-food, plant-based (WFPB) diet has an effect on metabolism, immune function, and disease activity in early-stage chronic lymphocytic leukemia (CLL). The main questions the study aims to answer are: * Does a WFPB diet influence disease progression? * How do CLL cells and other immune cell types respond to a WFPB diet in terms of metabolism and signaling? Researchers will examine whether a WFPB diet can affect absolute lymphocyte counts in participants' blood and what metabolic or functional changes occur within the CLL cells. Participants will: * Switch to a WFPB diet for 4 weeks following an introductory session with a certified dietary instructor. * Visit the clinic before starting the diet and again after 14 and 28 days for blood draws and to provide stool samples. * Keep a diary of all foods and drinks consumed during the week prior to and throughout the study period.
Eligibility
Inclusion Criteria: * Confirmed CLL diagnosis * No previous treatments (watch and wait) * Willingness to comply to a whole-food plant-based diet for 4 weeks * Willingness to participate in a total of 3 blood drawings Exclusion Criteria: * Emergency interventions * Patients that already follow a WFPB or vegan diet * Progression of CLL that implicates need for treatment * Insulin-dependent diabetes * Taking lipid-lowering medications (e.g. statins) * Body mass index (BMI) \<20 And if in the opinion of the investigator there are any concerns regarding the ability of the patient to complete the study safely.
Conditions2
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NCT07487428