Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07487428

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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