Actively Recruiting
Dietary Effects on Immune Function, Metabolism, and Disease Activity in Early-Stage Chronic Lymphocytic Leukemia
Led by Technical University of Munich · Updated on 2026-03-23
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a short-term, 4-week whole-food, plant-based (WFPB) diet affects metabolism, immune function, and disease activity in people with early-stage chronic lymphocytic leukemia (CLL) who have not yet received treatment. The study aims to understand if this diet influences disease progression and how CLL cells and other immune cells respond in terms of metabolism and signaling. Participants will follow a WFPB diet that excludes processed foods, animal products, sugar-sweetened, and alcoholic beverages. They will receive personalized nutrition counseling from a certified instructor and be encouraged to eat without quantity restrictions. The study includes three visits: before starting the diet, after 14 days, and after 28 days. At each visit, blood and stool samples will be collected, and body composition will be measured at the beginning and end. Throughout the study, participants will keep a food diary to monitor adherence. Researchers will evaluate changes in lymphocyte counts, immune cell composition, microbiome makeup, metabolism, blood lipids, body weight, and inflammatory markers. The study is exploratory and aims to generate insights into how diet might impact disease biology and systemic metabolism in early-stage CLL.
CONDITIONS
Brief Title
CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL)
- No previous treatments for CLL (watch and wait strategy)
- Willingness to follow a whole-food, plant-based diet for 4 weeks
- Willingness to undergo 3 blood draws during the study
You will not qualify if you...
- Need for emergency medical interventions
- Current adherence to a whole-food, plant-based or vegan diet
- Progression of CLL requiring treatment
- Insulin-dependent diabetes
- Use of lipid-lowering medications such as statins
- Body mass index (BMI) below 20
- Any concerns by the investigator regarding safe study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants follow a whole-food, plant-based diet for 4 weeks with individualized nutrition counseling and keep a food diary to monitor adherence.
3 visits at baseline, 14 days, and 28 days
Trial Site Locations
Total: 1 location
1
Klinikum der Technischen Universität München (Klinikum rechts der Isar)
München, Bavaria, Germany, 81676
Actively Recruiting
Research Team
M
Maike Buchner-Mayr, PD Dr.
A
Anna Herr, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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