RecruitingNAINTERVENTIONAL

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

This research, called CLL-IMPACT, explores if a short-term, whole-food, plant-based diet can make a difference for people with early-stage Chronic Lymphocytic Leukaemia (CLL) who are currently being monitored. For four weeks, participants will switch to this diet, guided by an expert. Researchers will then check blood and stool samples to understand how their bodies, immune system, and CLL cells respond. They want to see if the diet affects markers of the disease, how immune cells work, and overall body changes like weight and blood sugar. The main goal is to find out if this type of diet could influence the disease's activity and potentially offer new ways to support managing CLL.

At a glance

Status

Recruiting

Phase

Sponsor

Technical University of Munich

Enrolment target

Start

01 Jan 2024

Estimated completion

30 Jun 2028

CLL (Chronic Lymphocytic Leukemia)

What is this study about?

Imagine you have early-stage Chronic Lymphocytic Leukaemia (CLL) and your doctors are watching it closely, rather than giving you treatment right away. This study, called CLL-IMPACT, is designed to explore whether changing what you eat could play a role in managing your condition. Researchers are interested in a specific way of eating: a whole-food, plant-based diet, which means focusing on fruits, vegetables, grains, and beans, and avoiding processed foods and animal products.

The main idea behind this research is to see if eating this way for just four weeks can affect your body in several key ways. They will look at changes in your blood, specifically the number of CLL cells, and how your immune system is working. They also want to understand the chemical processes happening inside your body and within the CLL cells themselves. The hope is to learn if diet can influence the disease's activity and how your body fights it, potentially leading to new insights for people with CLL.

This isn't about finding a cure, but rather about understanding if food choices can be a helpful part of managing CLL. By carefully observing changes in participants' bodies during and after the diet, the researchers aim to gather important information. This could eventually help doctors and patients make informed decisions about lifestyle choices alongside their medical care for CLL.

Key takeaways

Exploring if a plant-based diet impacts early-stage CLL.
Participation involves a 4-week whole-food, plant-based diet.
Blood and stool samples will be collected to monitor changes.
Study aims to understand diet's effect on CLL cells and immune function.
You must be in the 'watch and wait' phase of CLL to be eligible.
Expert dietary guidance will be provided to participants.

Who may be eligible?

To be part of this study, you must have received a diagnosis of CLL and currently be in the 'watch and wait' phase, meaning you haven't started any treatments yet. A key part of joining is being willing to fully commit to a whole-food, plant-based diet for four weeks and attend all your clinic appointments, which include having blood taken.

However, some things would mean you couldn't take part. If you've already started a plant-based or vegan diet, or if your CLL has progressed and you need treatment, you wouldn't be eligible. Also, if you have insulin-dependent diabetes, take certain cholesterol-lowering medicines (like statins), or weigh less than what doctors consider a healthy range (with a BMI below 20), you wouldn't be able to join. The research team will also carefully check if there are any other health concerns that might make it unsafe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of CLL?
Am I currently on 'watch and wait' and not receiving any treatment for CLL?
Am I willing to commit to a whole-food, plant-based diet for four weeks?
Am I willing to attend all three clinic visits for blood and stool samples?
Do I have insulin-dependent diabetes or take specific cholesterol-lowering medicines?
Is my Body Mass Index (BMI) below 20?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your journey will start with an introductory session where a certified dietary expert will guide you on how to follow the whole-food, plant-based diet. For the next four weeks, this will be your diet – focusing on natural plant foods and avoiding animal products and highly processed items. You'll be encouraged to eat until you're satisfied, without strict portion limits.

You'll visit the clinic three times: once before you start the diet, then again after 14 days, and finally after 28 days. At each visit, you'll have blood samples taken and be asked to provide a stool sample. You'll also be asked to keep a detailed diary of everything you eat and drink, starting from the week before the study and throughout the entire four-week period. The total time you'll be actively involved in the diet and clinic visits is four weeks.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as gaining expert guidance on a healthy, plant-based diet and having a close look at how your body responds to it. You'd also be helping researchers understand better ways to manage CLL, which could benefit others in the future. However, there are also potential risks, like changes to your digestion as your body adjusts to a new diet, or the small discomforts linked with blood tests. While the diet is generally considered healthy, it's important to discuss any concerns with the study team. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Klinikum der Technischen Universität München (Klinikum rechts der Isar)
Verified postcode
München, Germany· Recruiting

Common questions

What exactly is a 'whole-food, plant-based diet'?

It's a way of eating that focuses on foods like fruits, vegetables, whole grains, beans, and nuts. It avoids all animal products and largely skips highly processed foods, sugary drinks, and alcohol.

Do I have to be a vegetarian or vegan already to join?

No, in fact, you cannot have been following a plant-based or vegan diet before joining the study.

Will I have to weigh my food or count calories?

No, you'll be encouraged to eat until you feel full, without restricting how much you eat. The focus is on the types of food, not the quantity.

How many times will I need to visit the clinic?

You will need to visit the clinic three times in total: once before starting the diet, and then another two times during the four-week study period.

What if I get hungry on the diet?

The diet encourages you to eat to your satisfaction. The dietary instructor will help you understand healthy, filling plant-based foods, so you shouldn't feel hungry.

How to find out more

Maike Buchner-Mayr, PD Dr.

maike.buchner@tum.de +498941409255 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.