CLL (Chronic Lymphocytic Leukemia)CLL-IMPACTNCT07487428
CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLL
A study testing Diet in people with CLL (Chronic Lymphocytic Leukemia), run by Technical University of Munich at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL (Chronic Lymphocytic Leukemia)
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinikum der Technischen Universität München (Klinikum rechts der Isar)
München, Bavaria, 81676
Manuel Knauer, Dr., Manuel.Knauer@mri.tum.de
About this study
Official title: An Interventional Study of Dietary Effects on Immune Function, Metabolism and Disease Activity in Early-Stage Chronic Lymphocytic Leukemia
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?
Read more
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.
Read the detailed description
This is a prospective, exploratory, single-arm pilot study designed as a pre-post comparison in which each participant serves as their own control. The aim of the trial is to investigate whether a short-term (4-week) whole-food, plant-based (WFPB) diet influences disease activity, immune function, and metabolism in patients with early-stage, treatment-naïve chronic lymphocytic leukemia (CLL) who are currently managed with a watch-and-wait strategy. Up to 50 participants will be enrolled.
The primary objective is to assess whether a WFPB diet impacts disease activity, as reflected by changes in absolute lymphocyte counts and other hematologic parameters. Secondary objectives include examining the effects of the dietary intervention on immune cell subsets, their signaling pathways, and cell-cell interactions. In addition, the study will evaluate changes in microbiome composition and related metabolic processes, as well as explore systemic metabolic shifts through targeted and untargeted omics analyses. These include metabolomics, lipidomics, and other exploratory omics approaches, conducted on a subset of participants.
Additional health-related outcomes will also be assessed. These include anthropometric and metabolic markers such as body weight, body mass index (BMI), body composition (lean mass and fat mass), blood glucose, lipid profiles, and systemic inflammatory markers. Stool samples will be analyzed for microbiome composition and metabolites, while blood samples will be used for flow cytometry-based immune profiling, signaling analyses, and exploratory omics assays.
The dietary intervention is defined as a whole-food, plant-based diet that excludes highly processed foods, minimizes intake of moderately processed foods, eliminates all animal-derived foods, and reduces consumption of sugar-sweetened and alcoholic products. Participants will be encouraged to eat to satiety without restriction on quantity. A certified dietary instructor will provide individualized counseling, taking into account each participant's baseline dietary habits and lifestyle. Adherence will be monitored through a food diary kept during the week prior to study initiation and throughout the 4-week intervention.
Study visits will take place at baseline (prior to dietary change), after 14 days, and after 28 days. At each visit, blood and stool samples will be collected, clinical assessments will be performed, and at day 0 and 28 body composition will be measured. The trial is exploratory in nature, aiming to generate hypotheses and mechanistic insights into the potential of a short-term dietary intervention to modulate disease biology and systemic metabolism in CLL.
- Conditions
- CLL (Chronic Lymphocytic Leukemia)
- Being tested
- Diet
- Keywords
- Diet, Nutrition, Plant-based diet
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on absolute lymphocyte count
Leukocyte and Lymphocyte count will be measured from whole blood via the in-houseclinical chemistry pipeline.
Measured: 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
Firmicutes to Bacteriodota ratio (%) will be analysed via 16S rRNA sequencing
Measured: Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28
Effect immune cell composition
Composition of immune cell populations will be investigated via Spectral Flow Cytometry-based phenotyping and given in %
Measured: Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28
Changes in Metabolism
Changes in concentration of metabolites via Metabolomics/Lipidomics from serum and PBMCs.
Measured: Before the intervention at day 0 and after the intervention at day 28
Changes in Serum lipids
Lipid concentrations will be evaluated by the clinics in house pipeline.
Measured: Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28.
Effect on body weight
Body weight is measured in kg
Measured: Before the intervention at day 0 and after the intervention at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Jan 2024
- Primary completion1 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL (Chronic Lymphocytic Leukemia)Studies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maike Buchner-Mayr, PD Dr., Principal investigator, Technisch Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487428
- Sponsor's protocol ID
- 2022-604-S-KH
- Other IDs
- 505372148
- Acronym
- CLL-IMPACT
- Status last verified
- Jul 2025
- First submitted
- 22 Sep 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will support the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. De-identified individual participant data collected during the trial will be shared, including clinical and laboratory data. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form will also be provided.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study of Dietary Effects on Immune Function, Metabolism and Disease Activity in Early-Stage Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT07487428
- Acronym / sponsor ID
- CLL-IMPACT / 2022-604-S-KH
- Conditions
- CLL (Chronic Lymphocytic Leukemia)
- Keywords
- Diet, Nutrition, Plant-based diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, exploratory, single-arm pilot study designed as a pre-post comparison in which each participant serves as their own control. The aim of the trial is to investigate whether a short-term (4-week) whole-food, plant-based (WFPB) diet influences disease activity, immune function, and metabolism in patients with early-stage, treatment-naïve chronic lymphocytic leukemia (CLL) who are currently managed with a watch-and-wait strategy. Up to 50 participants will be enrolled.
The primary objective is to assess whether a WFPB diet impacts disease activity, as reflected by changes in absolute lymphocyte counts and other hematologic parameters. Secondary objectives include examining the effects of the dietary intervention on immune cell subsets, their signaling pathways, and cell-cell interactions. In addition, the study will evaluate changes in microbiome composition and related metabolic processes, as well as explore systemic metabolic shifts through targeted and untargeted omics analyses. These include metabolomics, lipidomics, and other exploratory omics approaches, conducted on a subset of participants.
Additional health-related outcomes will also be assessed. These include anthropometric and metabolic markers such as body weight, body mass index (BMI), body composition (lean mass and fat mass), blood glucose, lipid profiles, and systemic inflammatory markers. Stool samples will be analyzed for microbiome composition and metabolites, while blood samples will be used for flow cytometry-based immune profiling, signaling analyses, and exploratory omics assays.
The dietary intervention is defined as a whole-food, plant-based diet that excludes highly processed foods, minimizes intake of moderately processed foods, eliminates all animal-derived foods, and reduces consumption of sugar-sweetened and alcoholic products. Participants will be encouraged to eat to satiety without restriction on quantity. A certified dietary instructor will provide individualized counseling, taking into account each participant's baseline dietary habits and lifestyle. Adherence will be monitored through a food diary kept during the week prior to study initiation and throughout the 4-week intervention.
Study visits will take place at baseline (prior to dietary change), after 14 days, and after 28 days. At each visit, blood and stool samples will be collected, clinical assessments will be performed, and at day 0 and 28 body composition will be measured. The trial is exploratory in nature, aiming to generate hypotheses and mechanistic insights into the potential of a short-term dietary intervention to modulate disease biology and systemic metabolism in CLL.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: DietAll participants will receive nutrition counselling and partake in the WFPB diet for 4 weeks. Participants will be asked to keep a food diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietFor 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. | Other | Dietary intervention |
Primary outcome
Effect on absolute lymphocyte count
Time frame: Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28
Leukocyte and Lymphocyte count will be measured from whole blood via the in-houseclinical chemistry pipeline.
5 secondary outcomes
Effect on Microbiomecomposition
Time frame: Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28
Effect immune cell composition
Time frame: Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28
Changes in Metabolism
Time frame: Before the intervention at day 0 and after the intervention at day 28
Changes in Serum lipids
Time frame: Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28.
Effect on body weight
Time frame: Before the intervention at day 0 and after the intervention at day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. We will support the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. De-identified individual participant data collected during the trial will be shared, including clinical and laboratory data. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form will also be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maike Buchner-Mayr, PD Dr. principal investigator
Technisch Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with CLL (Chronic Lymphocytic Leukemia), run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maike Buchner-Mayr, PD Dr. (+498941409255, Maike.Buchner@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on absolute lymphocyte count (time frame: Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.