Clinical Trials Logo

Clinical Trial Summary

The investigators will study the mechanistic details of dietary programming of the epigenome at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin D3. They will follow a small number of healthy adult volunteers individually over time while measuring per individual a large number of molecular and dynamic parameters that will be used for mechanistic modeling. The main hypothesis of the investigators is that nutritional components, such as vitamin D3, have a direct effect on the epigenome of the different cell types of the immune system. Using complementary in vivo, in vitro and in silico approaches, they will investigate the mechanistic basis of this dietary epigenetic programming process and how it creates memory.


Clinical Trial Description

Exposure to dietary molecules during adulthood creates an epigenetic memory in immune cells affecting disease risk in later years of life. Many nutritional molecules have a direct effect on the human genome and/or epigenome, since they (or their metabolites) activate transcription factors or chromatin modifiers. This process is the mechanistic basis of the discipline nutrigenomics. Thus, the daily diet of humans leads to changes in the transcriptome and epigenome of many tissues and cell types. In this way, many physiological functions of the human body, such as a well-responding immune system, are influenced by diet. Some of these effects are not only transient but may lead to persistent changes of the epigenome in many different tissues. However, the mechanistic details of this dietary programming of the epigenome are not well understood. Therefore, in this study, the investigators will study this process at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin D3. They will use the approach to follow a small but sufficient number of healthy adult volunteers (based on power calculation of self-controlled longitudinal studies) individually over time while measuring per individual a large number of molecular and dynamic parameters that will be used for mechanistic modeling, instead of investigating only few parameters from a large number of participants for statistical modeling. The main hypothesis of the investigators is that nutritional components, such as vitamin D3, have a direct effect on the epigenome of the different cell types of the immune system. Using complementary in vivo, in vitro and in silico approaches, they will investigate the mechanistic basis of this dietary epigenetic programming process and how it creates memory. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06104111
Study type Interventional
Source Polish Academy of Sciences
Contact Carsten Carlberg, PhD
Phone +48-89-523-4612
Email c.carlberg@pan.olsztyn.pl
Status Recruiting
Phase Phase 1
Start date October 1, 2023
Completion date March 30, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06055777 - Study of the Safety, Tolerability, and PK of SZEY-2108 Administered Intravenously to HVs in SAD and MAD Cohorts Phase 1
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Recruiting NCT05793983 - S100A8/A9 and Innate Immunity in Liver Disease
Active, not recruiting NCT05963269 - The Effect of the Game on Students' Intramuscular Injection Skills N/A
Not yet recruiting NCT06026852 - Validation of Betalactam ML Prediction Models - TDMAide N/A
Not yet recruiting NCT02222779 - Quantification of Transition Metals N/A
Completed NCT01976234 - Stored RBC Transfusion and Immonomodulation N/A
Completed NCT02345135 - Susceptibility to Infections in Ataxia Telangiectasia N/A
Completed NCT01530763 - Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP) Phase 2/Phase 3
Completed NCT01158560 - A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections Phase 3
Completed NCT01176786 - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery N/A
Active, not recruiting NCT05284097 - Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study Phase 2
Enrolling by invitation NCT06055712 - Antibiotic Prophylaxis in Pediatric Open Fractures Phase 4
Not yet recruiting NCT06338345 - Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients N/A
Not yet recruiting NCT06402292 - Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute N/A
Recruiting NCT06002685 - Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention N/A
Completed NCT02802059 - E. Coli Nissle 1917 - Suspension for Infection Prophylaxis Phase 3
Completed NCT05289674 - The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection N/A
Recruiting NCT05770765 - Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases
Completed NCT05389540 - Rural South and Southeast Asia Household Health Survey