Whole-food, plant-based diet for people with early-stage CLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, prospective pilot where each participant serves as their own control to test a 4-week whole-food, plant-based (WFPB) dietary intervention. Up to 50 treatment-naïve patients with early-stage CLL on a watch-and-wait strategy will receive an introductory session with a certified dietary instructor and switch to the WFPB diet. Clinic visits occur before the diet and at 14 and 28 days for blood draws, with stool samples collected and food diaries kept throughout. The study will measure changes in absolute lymphocyte counts, immune cell subsets and signaling, microbiome composition, and targeted and untargeted metabolic omics in a subset of participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Klinikum der Technischen Universität München (Klinikum rechts der Isar)
  München, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Maike Buchner-Mayr, PD Dr. — Technisch Universität München
• Study coordinator: Maike Buchner-Mayr, PD Dr.
• Email: Maike.Buchner@tum.de
• Phone: +498941409255

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.