NCT07487428 CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLL
| NCT ID | NCT07487428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technical University of Munich |
| Condition | CLL (Chronic Lymphocytic Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Maike Buchner-Mayr, PD Dr.
PRINCIPAL INVESTIGATOR
Technisch Universität München
Frequently Asked Questions
Who can join the NCT07487428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CLL (Chronic Lymphocytic Leukemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07487428 currently recruiting?
Yes, NCT07487428 is actively recruiting participants. Contact the research team at Maike.Buchner@tum.de for enrollment information.
Where is the NCT07487428 trial being conducted?
This trial is being conducted at München, Germany.
Who is sponsoring the NCT07487428 clinical trial?
NCT07487428 is sponsored by Technical University of Munich. The principal investigator is Maike Buchner-Mayr, PD Dr. at Technisch Universität München. The trial plans to enroll 50 participants.
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