NCT05432362

ESAN II - Energy Sensing in Depression

ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Immune System Tolerance
• Depression
• Obesity
• Microbial Colonization
• Diet, Healthy

Interventions

Type	Name	Description
OTHER	Aronia Juice	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.
OTHER	Placebo	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.

Timeline

• Start date: 2019-02-25
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2022-06-27
• Last updated: 2024-11-27

Locations

1 site across 1 country: Austria