Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL (Chronic Lymphocytic Leukemia) | Chronic Lymphocytic Leukemia | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dietary intervention
- description
- All participants will receive nutrition counselling and partake in the WFPB diet for 4 weeks. Participants will be asked to keep a food diary.
- interventionNames
- Other: Diet
Primary outcomes (1)
- measure
- Effect on absolute lymphocyte count
- timeFrame
- Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28
- description
- Leukocyte and Lymphocyte count will be measured from whole blood via the in-houseclinical chemistry pipeline.
Secondary outcomes (5)
- measure
- Effect on Microbiomecomposition
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available