NCT Number: NCT05432362
The purpose of this study is to assess the effects of polyphenols from natural aronia juice on the immune system.
Therefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as polyphenols and carotenoids in healthy and depressive subjects in order to use the known positive effects of these food sources in the therapeutic setting.
The consumption of natural fruit juices that are rich in polyphenols and carotenoids mirror a model of vegetarian diet due to the increased micronutrient density derived from plant food. Results obtained here can be seen as preliminary explanation models for the beneficial effects of vegetarian diet.
It is hypothesized, that the consumption of naturally polyphenol rich aronia juice changes the expression of regulatory T cells, specific cells of the immune system that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, the metabolome and the nutritional status are expected in the studied groups.
The study was registered retrospectively (after start of recruitment) on Clinicaltrials.gov.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Graz, Styria, 8010, Austria
Location status: Recruiting
Sabrina Mörkl, DDr.
SUB_INVESTIGATOR
Sandra Holasek, Prof.
CONTACT
Sonja Lackner, Dr.
CONTACT
Sonja Lackner, Dr.
SUB_INVESTIGATOR
Theresa Lahousen, Dr.
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is based an the additional consumption of 200 ml natural juice a day for a period of six weeks. The participants are asked to drink the natural and commercially available juice in addition to their regular diet. Further, they are asked not to change their diets and lifestyle behaviour during the intervention.
A beverage is prepared according to a known recipe. It contains macro- and micronutrients in comparable amounts like the aronia juice. It is completely polyphenol free.
Time frame: Determination at baseline (day 0) and after 6 weeks (after the intervention)
Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases.
Regulatory T cells (Treg) will be quantified using multiparameter flow cytometry. Monoclonal antibodies specific for surface markers such as CD3, CD4, CD45RA, CD39 and CD25 will be combined with intracellular anti-Foxp3 for the identification of human Treg.
Time frame: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. The assessment of Tregs after 12 weeks aims to identify any persisting effects of the intervention.
Time frame: Determination at baseline (day 0) and after 6 weeks (after the intervention)
Stool samples will be collected with the PSP spin stool DNA stool collection kit (Stratec, Birkenfeld, GER) and processed according to the suppliers recommendations. Subsequently to DNA extraction the variable V1-V2 region of the bacterial 16S rRNA gene is amplified with PCR using oligonucleotide primers BSF8 and BSR357.
Time frame: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Stool samples will be collected with the PSP spin stool DNA stool collection kit (Stratec, Birkenfeld, GER) and processed according to the suppliers recommendations. Subsequently to DNA extraction the variable V1-V2 region of the bacterial 16S rRNA gene is amplified with PCR using oligonucleotide primers BSF8 and BSR357. The assessment of the change in the gut microbiome after 12 weeks aims to identify any persisting effects of the intervention.
Time frame: Determination at baseline (day 0) and after 6 weeks (after the intervention)
The metabolome can be identified in various biological materials such as blood (EDTA and serum) Metabolites in blood will be analyzed by using 1H-NMR spectra. A non-targeted approach will be applied to characterize a potential shift in the participants' metabolic profile.
Time frame: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
The metabolome can be identified in various biological materials such as blood (EDTA and serum) Metabolites in blood will be analyzed by using 1H-NMR spectra. A non-targeted approach will be applied to characterize a potential shift in the participants' metabolic profile.The assessment of the change in the metabolome after 12 weeks aims to identify any persisting effects of the intervention.
Contact information is provided by the study sponsor or research team.
Sandra Holasek, Prof.
CONTACT
Sonja Lackner, Dr.
CONTACT
Medical University of Graz
Other
ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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