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NCT07487428Recruiting

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 · Last updated 23 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
22 Sept 2025
Start date
1 Jan 2024
Primary completion date
1 Jun 2028
Lead sponsor
Technical University of Munich
NCT number
NCT07487428

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Jan 2024 to the primary completion date, 1 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking lipid-lowering medications (e.g. statins)

Other illness

  • Insulin-dependent diabetes

Other

  • Emergency interventions
  • Patients that already follow a WFPB or vegan diet
  • Progression of CLL that implicates need for treatment
  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Klinikum der Technischen Universität München (Klinikum rechts der Isar)
Coordinator of this site? Confirm its status
MünchenGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.