CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLL
An Interventional Study of Dietary Effects on Immune Function, Metabolism and Disease Activity in Early-Stage Chronic Lymphocytic Leukemia
Technical University of Munich
50 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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 Criteria4
- 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 Criteria6
- 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.
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Interventions
For 4 weeks the participants will sick to a whole-food plant-based diet and keep a food diary. Recommendations and guidelines will be given during a nutritional counselling.
Locations(1)
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NCT07487428