Clinical Research Unit

The Clinical Research Unit (CRU) supports the translation of innovative biomedical preclinical research questions into clinical application in humans.

The CRU is part of the Experimental & Clinical Research Center (ECRC), a cooperation of MDC and Charité that promotes the collaboration between basic scientists and clinical researchers. The CRU focuses on the development of new approaches for diagnosis, prevention and therapy of cardiovascular and metabolic diseases, cancer and neurological diseases.

The CRU team supports scientists and clinicians in testing their preclinical scientific hypotheses in clinical studies with healthy volunteers and/or patients.

We offer a wide range of services in conducting clinical studies, such as study design conception, administration, recruitment, study visits, data analysis, interpretation and publication, either in a supporting or leading role. We have comprehensive expertise in the field of metabolic and cardiovascular research and are always open to further interdisciplinary and methodological approaches.

Interviews with Anja Mähler

Press Release No. 42 September 02, 2022 Berlin

How a receptor contributes to inflammation

What role do a common receptor and diet play in chronic inflammation? That is the question that the Experimental and Clinical Research Center (ECRC) and other partners will pursue over the next three years in a consortium project funded by the BMBF.

Science December 14, 2020

In charge of the chambers

Many researchers would like to see the results of their work put to use in practical applications. Anja Mähler helps to make this a reality. She leads the Clinical Research Unit at the , which carries out studies to test basic research findings. We paid her a visit for our series “We at the MDC”.

Science August 12, 2019

Podcast episode 6 - Can you lower blood pressure with bacteria?

Dr. Anja Mähler on the BIH podcast "From research to health" on the topic of the microbiome and what this totality of intestinal bacteria has to do with high blood pressure.

Group Leader

Dr. Anja Mähler
Clinical Research Unit (CRU)
Experimental and Clinical Research Center (ECRC)
Phone: +49 30 450 540 323
anja.maehler@charite.de | ORCID

Clinicians

Dr. Michael Boschmann
michael.boschmann@charite.de | ORCID

Dr. Nadja Siebert
nadja.siebert@charite.de | ORCID

Scientists

Dr. Sylvia Bähring
sylvia.baehring@charite.de | ORCID (TBA)

Dr. Kristin Kräker
kristin.kraeker@charite.de | ORCID

Till Schütte
till.schuette@charite.de | ORCID

Study nurses

Gabriele Rahn
gabriele.rahn@charite.de

Elena Steinle
elena.steinle@charite.de

Heike Schenck
heike.schenck@charite.de

Elisabeth Wernick
elisabeth.wernick@charite.de

Alumni

L. S. Bahr

S. Klamer

A. R. Rivera | ORCID

Core modules of the CRU

Comprehensive consulting
Study design conception
Administrative preparation (ethics vote, registration, etc.)
Recruitment of study participants
Execution of study visits
Configuration and maintenance of the clinical database (REDCap)
Standardized collection and preanalytics of various biomaterials
Data management, integrity assurance and data analysis
Scientific and medical documentation, communication and publication

The CRU applies a variety of state-of-the-art methods for metabolic, cardiovascular, visual and neurological phenotyping.

Central methods of the CRU

Metabolic phenotyping

Indirect calorimetry using the canopy method and metabolic chamber to quantify energy expenditure and substrate oxidation rates
Determination of body composition by air displacement plethysmography, bioelectrical impedance analysis and skinfold thickness
Microdialysis of adipose tissue and skeletal muscle to evaluate tissue perfusion, carbohydrate and lipid metabolism
Normobaric hypoxia chamber to study physiological effects of decreased oxygen concentration in ambient air
Continuous glucose monitoring over 14 days
Accelorometry for physical activity recording
Assessment of dietary patterns and quantification of nutrient intake

Cardiovascular phenotyping

Cardiopulmonary exercise testing to assess physical performance and quantify training effects (treadmill, cycle ergometer)
Standardized measurement of 24h and office blood pressure (brachial, central) and peripheral resistance
Schellong test
Flow-mediated dilatation of brachial artery
Noninvasive assessment of endothelial dysfunction
Measurement of advanced glycation end products (AGEs)
Dynamic retinal vessel analysis to assess vascular function
Measurement and analysis of pulse waveform to assess vascular stiffness (PulsePen).

Visual phenotyping

Imaging of retina, macula and optic nerve head using a fundus camera
Optical coherence tomography
Visual acuity tests
Measurement of intraocular pressure

Neurological phenotyping

Neurological status
Cognitive tests
Olfactory test
Hand grip measurement

Mahler A, Schutte T, Steiniger J, Boschmann M. The Berlin-Buch respiration chamber for energy expenditure measurements. Eur J Appl Physiol. 2023. PMID 36849666.

Spranger L, Weiner J, Bredow J, et al. Thrifty energy phenotype predicts weight regain in postmenopausal women with overweight or obesity and is related to FGFR1 signaling. Clin Nutr. 2023. PMID 36863292.

Gerhalter T, Muller C, Maron E, et al. "suMus," a novel digital system for arm movement metrics and muscle energy expenditure. Front Physiol. 2023. PMID 36776973.

Sperber PS, Brandt AU, Zimmermann HG, et al. Berlin Registry of Neuroimmunological entities (BERLimmun): protocol of a prospective observational study. BMC Neurol. 2022. PMID 36517734.

Jeran S, Steinbrecher A, Haas V, et al. Prediction of activity-related energy expenditure under free-living conditions using accelerometer-derived physical activity. Sci Rep. 2022. PMID 36195647.

Riveros-Rivera A, Penzel T, Gunga HC, et al. Hypoxia Differentially Affects Healthy Men and Women During a Daytime Nap With a Dose-Response Relationship: a Randomized, Cross-Over Pilot Study. Front Physiol. 2022. PMID 35685284.

Mahler A, Klamer S, Maifeld A, et al. Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study. Nutrients. 2022. PMID 35057434.

Bahr LS, Franz K, Mahler A. Assessing the (anti)-inflammatory potential of diets. Curr Opin Clin Nutr Metab Care. 2021. PMID 34155152.

Geisberger S, Bartolomaeus H, Neubert P, et al. Salt Transiently Inhibits Mitochondrial Energetics in Mononuclear Phagocytes. Circulation. 2021. PMID 33906377.

Bartolomaeus TUP, Birkner T, Bartolomaeus H, et al. Quantifying technical confounders in microbiome studies. Cardiovasc Res. 2021. PMID 32374853.

Maifeld A, Bartolomaeus H, Lober U, et al. Fasting alters the gut microbiome reducing blood pressure and body weight in metabolic syndrome patients. Nat Commun. 2021. PMID 33785752.

Kozarzewski L, Maurer L, Mahler A, Spranger J, Weygandt M. Computational approaches to predicting treatment response to obesity using neuroimaging. Rev Endocr Metab Disord. 2021. PMID 34951003.

Koppold-Liebscher DA, Klatte C, Demmrich S, et al. Effects of Daytime Dry Fasting on Hydration, Glucose Metabolism and Circadian Phase: A Prospective Exploratory Cohort Study in Baha'i Volunteers. Front Nutr. 2021. PMID 34395487.

Mahler A, Jahn C, Klug L, et al. Metabolic Response to Daytime Dry Fasting in Baha'i Volunteers-Results of a Preliminary Study. Nutrients. 2021. PMID 35011024.

Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020. PMID 33375942.

Boschmann M, Kaiser N, Klasen A, et al. Effects of dietary protein-load and alkaline supplementation on acid-base balance and glucose metabolism in healthy elderly. Eur J Clin Nutr. 2020. PMID 32873957.

Mai K, Klug L, Rakova N, et al. Hypoxia and exercise interactions on skeletal muscle insulin sensitivity in obese subjects with metabolic syndrome: results of a randomized controlled trial. Int J Obes (Lond). 2020. PMID 31819201.

Bahr LS, Bock M, Liebscher D, et al. Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. Trials. 2020. PMID 31898518.

Aktas MF, Mahler A, Hamm M, et al. Lifestyle interventions in Muslim patients with metabolic syndrome-a feasibility study. Eur J Clin Nutr. 2019. PMID 30538299.

Klug L, Mahler A, Rakova N, et al. Normobaric hypoxic conditioning in men with metabolic syndrome. Physiol Rep. 2018. PMID 30565412.

Mahler A, Balogh A, Csizmadia I, et al. Metabolic, Mental and Immunological Effects of Normoxic and Hypoxic Training in Multiple Sclerosis Patients: A Pilot Study. Front Immunol. 2018. PMID 30555484.

Haas V, Stengel A, Mahler A, et al. Metabolic Barriers to Weight Gain in Patients With Anorexia Nervosa: A Young Adult Case Report. Front Psychiatry. 2018. PMID 29867616.

Wilck N, Matus MG, Kearney SM, et al. Salt-responsive gut commensal modulates TH17 axis and disease. Nature. 2017. PMID 29143823.

Haufe S, Engeli S, Kaminski J, et al. Branched-chain amino acid catabolism rather than amino acids plasma concentrations is associated with diet-induced changes in insulin resistance in overweight to obese individuals. Nutr Metab Cardiovasc Dis. 2017. PMID 28958691.

Klaer J, Mahler A, Scherbakov N, et al. Longer-term impact of hemiparetic stroke on skeletal muscle metabolism-A pilot study. Int J Cardiol. 2017. PMID 28063669.

Adler C, Steinbrecher A, Jaeschke L, et al. Validity and reliability of total body volume and relative body fat mass from a 3-dimensional photonic body surface scanner. PLoS One. 2017. PMID 28672039.

Mossakowski AA, Pohlan J, Bremer D, et al. Tracking CNS and systemic sources of oxidative stress during the course of chronic neuroinflammation. Acta Neuropathol. 2015. PMID 26521072.

Haufe S, Kaminski J, Utz W, et al. Differential response of the natriuretic peptide system to weight loss and exercise in overweight or obese patients. J Hypertens. 2015. PMID 25882864.

Mahler A, Steiniger J, Bock M, et al. Metabolic response to epigallocatechin-3-gallate in relapsing-remitting multiple sclerosis: a randomized clinical trial. Am J Clin Nutr. 2015. PMID 25733633.

Mahler A, Steiniger J, Endres M, Paul F, Boschmann M, Doss S. Increased catabolic state in spinocerebellar ataxia type 1 patients. Cerebellum. 2014. PMID 24604678.

Haufe S, Haas V, Utz W, et al. Long-lasting improvements in liver fat and metabolism despite body weight regain after dietary weight loss. Diabetes Care. 2013. PMID 23963894.

Szabo T, Postrach E, Mahler A, et al. Increased catabolic activity in adipose tissue of patients with chronic heart failure. Eur J Heart Fail. 2013. PMID 23696611.

Pakula A, Schneider J, Janke J, et al. Altered expression of cyclin A 1 in muscle of patients with facioscapulohumeral muscle dystrophy (FSHD-1). PLoS One. 2013. PMID 24019929.

Mahler A, Mandel S, Lorenz M, et al. Epigallocatechin-3-gallate: a useful, effective and safe clinical approach for targeted prevention and individualised treatment of neurological diseases? EPMA J. 2013. PMID 23418936.

Mahler A, Steiniger J, Bock M, et al. Is metabolic flexibility altered in multiple sclerosis patients? PLoS One. 2012. PMID 22952735.

Haufe S, Utz W, Engeli S, et al. Left ventricular mass and function with reduced-fat or reduced-carbohydrate hypocaloric diets in overweight and obese subjects. Hypertension. 2012. PMID 22068866.

Haufe S, Engeli S, Kast P, et al. Randomized comparison of reduced fat and reduced carbohydrate hypocaloric diets on intrahepatic fat in overweight and obese human subjects. Hepatology. 2011. PMID 21400557.

Boschmann M, Engeli S, Moro C, et al. LMNA mutations, skeletal muscle lipid metabolism, and insulin resistance. J Clin Endocrinol Metab. 2010. PMID 20130076.

Here you can find recruiting and recent studies conducted at the CRU.

Recruiting studies

Aim of the study

Epidemiological studies have shown that preeclamptic pregnancy increases cardiovascular risk up to fourfold. In this study, we want to investigate vascular function at different body parts (myocardium, upper arm, fingertips, and fundus of the eye) and identify potential biomarkers for early detection of increased long-term risk. For this, we are recruiting subjects after a preeclamptic pregnancy and healthy controls.

NCT-Nummer: NCT05277233

Duration: 2021-ongoing

We are looking for Probands!

Aim of the study

Vasospastic angina, also called Prinzmetal's angina or "syndrome X," is caused by epicardial coronary artery spasm and results in atypical chest pain whether or not the patient is under physical stress. The exact mechanism leading to vasospastic angina is not yet fully elucidated. Non-invasive dynamic imaging of the retinal vessels using the "retinal flicker test", which allows measurement of microvascular function, is considered a promising approach. The aim of this study is to correlate coronary and retinal vascular function.

DRKS number: DRKS00030728

Duration: 2022-ongoing

Aim of the study

Pregnancies resulting from oocyte-donation have a strikingly increased risk of developing preeclampsia. The aim of this study is to investigate the interplay between various immune and placental cells and their potential to cause pregnancy-related diseases after conception from oocyte-donation. We will investigate if immune cell subtypes are causally involved in the development of preeclampsia by triggering endothelial imbalance and leading to increased cardiovascular risk later in life.

NCT number: NCT04731012

Duration: 2021-ongoing

We are looking for Probands!

Aim of the study

High blood pressure is a major risk factor for cardiovascular events such as stroke, heart and kidney failure. Typical antihypertensive drugs exert their effects on vessels, the kidneys or the heart. In this randomized, placebo-controlled trial, we test the antihypertensive effect of a probiotic in patients with grade 1 hypertension (130-159 and/or 80-99 mmHg). In addition, we will assess glucose variability, gut microbiome composition, bacterial metabolites in stool and blood, frequency of peripheral immune cells, and health-related quality of life.

NCT number: NCT03906578

Duration: 2019-ongoing

We are looking for Patients!

Aim of the study

The aim of the study is to investigate causal relationships between alterations in kidney function and alterations in the immune system and gut microbiome. For this purpose, couples of donor and recipient of living kidney donations residing in the same household will be observed.

NCT number: NCT05570929

Duration: 2022-ongoing

We are looking for Patients!

Aim of the study

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system primarily affecting women. It usually first appears between the ages of 20 and 40, a period of life associated with family planning and the desire to have children. In the past, pregnancy in MS patients was thought to be a risk, and in some cases, even abortion was recommended. This still causes doubt and uncertainty in MS patients and their partners. This study aims to assess the impact of pregnancy on MS by studying its course (number of relapses, disability progression, relapse symptoms, administered therapies, response to therapy) before, during and after pregnancy.

NCT number: NCT05010902

Duration: 2021-ongoing

We are looking for Patients!

Aim of the study

Patients with chronic kidney disease (CKD) exhibit an altered composition of the gut microbiota (dysbiosis) compared to healthy individuals, which is accompanied by a disturbed gut barrier. This dysbiosis is, among others, a consequence of a low-fiber diet. In this randomized, placebo-controlled study, we will investigate the effects of the prebiotic inulin on CKD course, gut microbiome composition, gut epithelial barrier, bacterial metabolites, immune cells and acid-base status.

NCT number: NCT05071131

Duration: 2021-ongoing

We are looking for Patients!

Aim of the study

An unbalanced Western diet, rich in salt, saturated fat, and processed animal products is considered as an independent risk factor for the development of chronic kidney disease (CKD) and multiple sclerosis (MS). Mechanistically, the aryl hydrocarbon receptor (AhR) may be involved. We want to characterize the diet-dependent AhR-mediated mechanisms in patients* with CKD and MS to reduce associated inflammation. Therfore, we are recruiting patients with CKD and MS.

DRKS number: DRKS00030864

Duration: 2023-ongoing

We are looking for Patients!

Recent studies - not recruiting

Aim of the study

During moderate and high physical activity, the skeletal muscle requires glucose oxidation in addition to fatty acids to meet its energy requirements. This glucose is primarily derived from intramuscular glycogen stores. Consequently, impaired energy supply from glucose leads to reduced muscular performance. Genetic muscular dystrophies are commonly associated with impaired glucose tolerance. However, the metabolic phenotype of facioscapulohumeral muscular dystrophy (FSHD) is still unclear. In this study, we investigate changes of energy metabolism in FSHD patients compared to healthy controls. We hypothesize that mitochondrial dysfunction leads to impaired glucose tolerance and insulin sensitivity, which in turn contribute to exercise intolerance.

NCT number: NCT05052073

Duration: 2009-ongoing, not recruiting

Aim of the study

This study examines the effects of a 5-day Buchinger fast on energy metabolism, body composition, office blood pressure, gut microbiome, various metabolic and immune parameters, glucose variability, and neuronal mechanisms of emotion processing and food-specific delayed gratification in healthy adults. Medium-term effects will be verified 3 months after the fast.

NCT number: NCT04452916

Duration: 2020-ongoing, not recruiting

Aim of the study

This study investigates the efficacy of three nutritional approaches on disease progression in patients with multiple sclerosis (MS). These approaches are 1) 7-day fasts every 6 months and 14h intermittent fasting in between, 2) a diet high in fat and low in carbohydrates (ketogenic diet), and 3) an anti-inflammatory, primarily plant-based diet according to the recommendations of the German Nutrition Society (DGE). We hypothesize that the efficacy of the diets differs with respect to new brain MRI lesions, MS disability progression, relapse rate, quality of life, gut microbiome composition, and various metabolic markers.

NCT number: NCT03508414

Study protocol

Duration: 2017-2021

Epidemiological studies have shown that preeclamptic pregnancy increases cardiovascular risk up to fourfold. In this study, we aim to investigate vascular function at different body parts (myocardium, upper arm, fingertips and fundus of the eye) and to identify potential biomarkers for early detection of increased long-term risk.

To do this, we are looking for subjects after a preeclamptic pregnancy and healthy controls, whose first pregnancy was 5 to 10 years ago.

The study is conducted in the Clinical Research Unit of the Experimental & Clinical Research Center at the Charité Campus Berlin-Buch, as well as at the Helios Klinikum Berlin-Buch in two visits. The total time required is approximately 6 hours. An appropriate financial allowance is guaranteed.

You will also receive:

A magnetic resonance tomography (MRT) of the heart
Individual information about body composition, blood pressure and vascular stiffness
Assessment of visual acuity, as well as an analysis of retinal vasculature

You can find more information at the study register of Charité.

Have we met your interest? Then please contact us at:

(030) 450 540 565 or carpe@charite.de.

The aim of this study is to develop a non-invasive diagnostic method for vasospastic angina. We will deploy a state-of-the-art method for dynamic vascular imaging of the retinal microvasculature ("retinal flicker test"). In addition, further insights into the pathomechanism underlying coronary vasospasm will be investigated by molecular biological analyses.

You will receive a comprehensive eye examination (approx. 45 min):

Intraocular pressure measurement
Visual acuity test using autorefractometer
High-resolution retinal image and periphery by ultra-widefield funduscopy
2-Dimensional imaging of the ocular fundus via optical coherence tomography (OCT)
Determination of endothelial function by means of dynamic vascular analysis (DVA).

Subsequently, you are unable to drive for about 4 hours, as a measurement-related pupil dilatation (mydriasis) is performed.

The study visit will be conducted in the Clinical Research Unit of the Experimental & Clinical Research Center at the Charité Campus Berlin-Buch.

More information can be found in the Charité study register (TBA).

Are you...

over 18 years old and became pregnant
by natural means or
through IVF and/or ICSI treatment or
through egg donation?

... then, we invite you to participate in our scientific study.

What do you have expect during the study?

We will examine you up to three times during your pregnancy and perform a general health check including a blood sample drawing. If we discover any abnormal findings, we will offer treatment in our specialized outpatient clinics.

You will receive a reasonable expense allowance for your participation. You might refuse examinations at any time. All data will be handled in a strictly confidential way.

What is the purpose of the study?

It is already known that pregnant women have an increased risk of hypertension during and after pregnancy due to egg donation. We aims to develop improved therapies that can address the specific needs of these women.

You can find more information at the study register of Charité.

Are you interested? Then please contact us by phone or email:

(030) 450 540 565 or ecrc-schwangerschaftsstudie@charite.de.

Subject: Egg donation

Is your blood pressure either treated or untreated above 130/80? Are you between 50 and 80 years? Are you looking for an alternative treatment that can lower your blood pressure?

Then our HYPRO study would be just right for you! We are investigating the influence of a probiotic (preparation of viable bacteria) on blood pressure, the intestinal microbiome and glucose metabolism.

You can find more information at the study register of Charité.

If you are interested, please contact us at:

(030) 450 540 565 / 234 or hypro@charite.de.

Acute and chronic kidney disease are frequently and rising worldwide. In the final stage of kidney disease only hemodialysis or a kidney transplant are available as treatment options. We would like to investigate the influence of loss and gain of a healthy kidney after transplantation in donor couples.

The study will be conducted at the Experimental & Clinical Research Center (ECRC) in Berlin-Buch.

We are looking for

Men and women
Between 18 to 75 years old
Pending living kidney donation
Donor and recipient of the kidney living in the same household

Your benefits:

A thorough health check
Individualized information about body composition and blood pressure
A detailed dietary analysis
An appropriate financial allowance

You can find more information at the study register of Charité.

If you are interested, please contact us at:

(030) 450 540 234 or longkid@charite.de.

Pregnancy brings about many chances in a woman’s body and affects the course of multiple sclerosis (MS). In this cohort study, we accompany MS patients before, during and after a pregnancy, in order to study the pregnancies’ influence on MS and counsel patients individually.

Every three months we will:

Evaluate general and neurological status
Ask for depression, sleep quality, fatigue and quality of life
Take blood samples
Non-invasively investigate the retina by optical coherence tomography (OCT)
Perform a brain MRI (only before and after pregnancy)

Allowance: 25 Euro/visit (max. 9 visits)

You can find more information at the study register of Charité.

If you are interested, please contact:

Charité - University Medicine Berlin

Clinical Research Unit (CRU)

Experimental and Clinical Research Center (ECRC)

(030) 450 540 565 or precoms@charite.de.

Patients with chronic renal failure often have an unfavorable composition of bacteria in the gut (dysbiosis), which can increase the permeability of the intestinal wall and stimulate inflammatory processes. We would like to investigate whether the prebiotic inulin can positively influence this dysbiosis and the permeability of the intestinal wall.

For this, we are recruiting men and women with renal failure requiring dialysis who are between 18 and 70 years.

The study will be conducted at the Experimental & Clinical Research Center (ECRC) in Berlin-Buch.

Your benefits:

A thorough health check
Individualized information about body composition, blood pressure and vascular stiffness
A detailed dietary analysis and individualized nutritional counselling
An appropriate financial allowance

You can find more information at the study register of Charité.

If you are interested, please contact us at:

(030) 450 540 464 or restore@charite.de.

Chronic kidney disease and multiple sclerosis are progressive diseases. The individual course and response to common therapies are difficult to predict. This is mainly due to the fact that the underlying disease mechanisms are only partially known. This study aims to make a decisive contribution to this. Our starting points are nutrition, the gut microbiome and microbial metabolites. The study will be conducted at the Experimental & Clinical Research Center (ECRC) in Berlin-Buch.

We are looking for

men and women
age 18 bis 50 Jahre

With either

chronic renal failure stage 3 or
relapsing multiple sclerosis

You get

a detailed health check
individual information about body composition, blood pressure and vascular stiffness
a whole food, plant-based diet for 5 days
an appropriate allowance for expenses

You can find more information at the study register of Charité (TBA).

Have we met your interest? Then please contact us at:

(030) 450 540 234 or tahrget@charite.de.