About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Emergency interventions
Patients that already follow a WFPB or vegan diet
Progression of CLL that implicates need for treatment
Insulin-dependent diabetes
Trial design
Single group
Treatments tested in this trial
Diet
Other interventionFor 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.
Treatment groups
Trial outcomes
Primary outcomes
Effect on absolute lymphocyte count
Leukocyte and Lymphocyte count will be measured from whole blood via the in-houseclinical chemistry pipeline.
Secondary outcomes
Effect on Microbiomecomposition
Firmicutes to Bacteriodota ratio (%) will be analysed via 16S rRNA sequencing
Effect immune cell composition
Composition of immune cell populations will be investigated via Spectral Flow Cytometry-based phenotyping and given in %
Changes in Metabolism
Changes in concentration of metabolites via Metabolomics/Lipidomics from serum and PBMCs.
Changes in Serum lipids
Lipid concentrations will be evaluated by the clinics in house pipeline.
Sponsors and contacts
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