Clinical Research Unit

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.

CRU in the media (interviews, youtube, podcast, tv, ...)

Science August 27, 2024

Galileo: Kitchen Star or Health Risk? Salt Consumption Under Scrutiny

You hear it all the time: too much salt in food is unhealthy. But when is salt really too much? And what effects does it have on our body? "Galileo" reporter Martin Dunkelmann takes on the experiment.

Science November 03, 2023

Preeclampsia: What tiny veins can tell us

There are few pregnancy diseases as life-threatening as preeclampsia. But the danger doesn’t end after birth: Mothers with preeclamptic pregnancies have a much higher risk of developing cardiovascular disease later in life. Kristin Kräker from the Experimental and Clinical Research Center is working on an early warning system.

Science May 31, 2023

How diseases begin in the gut

A Berlin-based team led by ECRC researcher Dominik N. Müller is analyzing how inflammation of the intestinal mucosa affects blood vessels. They are still looking for study participants – especially people with inflammatory bowel diseases, multiple sclerosis, high blood pressure and diabetes.

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 ECRC , which carries out studies to test basic research findings. We paid her a visit for our series “We at the MDC”.

Science January 31, 2020

Paper of the month January 2020: Interview with Kristin Kräker and Nadine Haase

In January, Dr. Kristin Kräker and Dr. Nadine Haase were awarded the "Paper of the Month" for their study on preeclampsia, published in Hypertension. Both researchers work at the ECRC, the Experimental and Clinical Research Center of Charité and the Max Delbrück Center.

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.

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

2023

 

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.

2022

 

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.

2021

 

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.

2020

 

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.

2019

 

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.

2018

 

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.

2017

 

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.

2015 - 2010

 

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.

Recruiting studies

CARPE

Endothelial function and cardiovascular risk after preeclamptic pregnancy.

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!

ChronoMS

Circadian mechanisms of metabolism and inflammation in multiple sclerosis

The aim of the project is to characterize metabolic and immunological circadian rhythms in patients with multiple sclerosis (MS) compared to healthy subjects. In addition, we want to investigate whether impaired retino-hypothalamic tract (RHT) integrity contributes to circadian disruption in MS.

Study ID: DRKS00035226

Duration 2024-ongoing

We are looking for Patients/Probands!

CORAL

Retinal vascular function in vasospastic angina.

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-ID: DRKS00030728

Duration: 2022-ongoing

ED-S

Immunological and cardiovascular phenotyping of oocyte-donation pregnancies.

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!

LONGKID

Alterations in living kidney donations with respect to renal function, immune system and gut microbiome.

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!

MEDIATE

Immunological and metabolic effects of dietary methionine restriction in healthy volunteers.

Aim of the study

Methionine is an essential amino acid found in all living organisms and is consumed through the diet. The aim of this study is to investigate the effects of two-week methionine restriction (MR) on autophagy, immune function, body composition, blood pressure, pulse wave velocity, and amino acid and metabolite composition in plasma and urine of healthy volunteers. Furthermore, we will investigate whether these parameters are reversible after reintroducing methionine into the diet.

DRKS-ID: DRKS00032816

Duration: 2023-ongoing

We are looking for Probands!

PRECOMS

Pregnancy cohort in multiple sclerosis.

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!

RESTORE

Effect of inulin on gut microbiota and gut barrier in chronic kidney disease.

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!

TAHRGET

Characterization of dietary AhR-dependent immune responses in patients with chronic kidney disease and multiple sclerosis

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-ID: DRKS00030864

Duration: 2023-ongoing

We are looking for Patients!

Recent studies - not recruiting

FSHD

Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity.

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: 2009-2024, not recruiting

HYPRO

Effects of a probiotic on hypertension.

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, not recruiting

LEANER

Physiological response to 5 days fasting.

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: 2020-2024, not recruiting

NAMS

Nutritional Approaches in Multiple Sclerosis.

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