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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnical University of Munich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Emergency interventions

Patients that already follow a WFPB or vegan diet

Progression of CLL that implicates need for treatment

Insulin-dependent diabetes

Trial design

Design model

Single group

Treatments tested in this trial

  • Diet

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Dietary interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effect on absolute lymphocyte count

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

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

Secondary outcomes

1

Effect on Microbiomecomposition

Firmicutes to Bacteriodota ratio (%) will be analysed via 16S rRNA sequencing

Time frame
Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28
2

Effect immune cell composition

Composition of immune cell populations will be investigated via Spectral Flow Cytometry-based phenotyping and given in %

Time frame
Before the intervention at day 0, during the intervention at day 14 and after the intervention at day 28
3

Changes in Metabolism

Changes in concentration of metabolites via Metabolomics/Lipidomics from serum and PBMCs.

Time frame
Before the intervention at day 0 and after the intervention at day 28
4

Changes in Serum lipids

Lipid concentrations will be evaluated by the clinics in house pipeline.

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

Other outcomes

Sponsors and contacts

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