Whole-food, plant-based diet for people with early-stage CLL
An Interventional Study of Dietary Effects on Immune Function, Metabolism and Disease Activity in Early-Stage Chronic Lymphocytic Leukemia
NA · Technical University of Munich · NCT07487428
See if a 4-week whole-food, plant-based diet changes immune activity and blood counts in people with early-stage, untreated CLL.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich (other) |
| Locations | 1 site (München, Bavaria) |
| Trial ID | NCT07487428 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with confirmed early-stage, treatment-naïve CLL managed with watch-and-wait who are willing to follow a whole-food, plant-based diet for 4 weeks, attend three clinic visits, and have BMI ≥20 are ideal candidates.
Not a fit: Patients who already follow a WFPB or vegan diet, those with progressive disease requiring treatment, insulin-dependent diabetics, people taking lipid-lowering medications like statins, or those unable to safely complete the protocol are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this could offer a low-risk dietary approach to lower lymphocyte counts or improve immune and metabolic markers in early-stage CLL.
How similar studies have performed: Diet and microbiome interventions have produced immune and metabolic changes in other conditions, but direct evidence for this approach in CLL is limited and largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
München, Bavaria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: CLL, Diet, Nutrition, Plant-based diet