CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLL

NCT07487428 | Recruiting

• 2 other identifiers: 2022-604-S-KH505372148
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CLL (Chronic Lymphocytic Leukemia)

Keywords

Diet; Nutrition; Plant-based diet

Outcome Measures

Primary Outcomes (1)

• Effect on absolute lymphocyte count

  Leukocyte and Lymphocyte count will be measured from whole blood via the in-houseclinical chemistry pipeline.

  Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28

Secondary Outcomes (5)

• Effect on Microbiomecomposition

  Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28

• Effect immune cell composition

  Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28

• Changes in Metabolism

  Before the intervention at day 0 and after the intervention at day 28

• Changes in Serum lipids

  Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28.

• Effect on body weight

  Before the intervention at day 0 and after the intervention at day 28

Study Arms (1)

Dietary intervention

EXPERIMENTAL

All participants will receive nutrition counselling and partake in the WFPB diet for 4 weeks. Participants will be asked to keep a food diary.

Other: Diet

Interventions

Diet OTHER

For 4 weeks the participants will sick to a whole-food plant-based diet and keep a food diary. Recommendations and guidelines will be given during a nutritional counselling.

Dietary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum der Technischen Universität München (Klinikum rechts der Isar)

München, Bavaria, 81676, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, B-Cell

Interventions

Diet

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Maike Buchner-Mayr, PD Dr.

  Technisch Universität München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maike Buchner-Mayr, PD Dr.

CONTACT

+498941409255; Maike.Buchner@tum.de

Anna Herr, MSc

CONTACT

+498941404159; Anna.Herr@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: March 23, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 23, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data sharing will begin 9 months after the primary results are published and will be available for up to 3 years. Extensions may be considered upon request.
• Access Criteria: Data access will be granted to qualified researchers from academic or non-profit institutions following review and approval of a research proposal and execution of a data sharing agreement. Requests should be submitted via email to Maike Buchner-Mayr.

Locations

DE (1)