NCT05432362

ESAN II - Energy Sensing in Depression

Recruiting now NA Last updated 27 November 2024

What this trial tests

NA trial testing Aronia Juice in Immune System Tolerance in 120 participants. Currently enrolling.

Timeline

25 February 2019

Primary endpoint
31 January 2026

31 January 2026

Quick facts

Lead sponsor	Medical University of Graz
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	120
Start date	25 February 2019
Primary completion	31 January 2026
Estimated completion	31 January 2026
Sites	1 location across Austria

Drugs / interventions tested

• Aronia Juice
• Placebo

Conditions studied

• Immune System Tolerance — all drugs for Immune System Tolerance →
• Depression — all drugs for Depression →
• Obesity — all drugs for Obesity →
• Microbial Colonization — all drugs for Microbial Colonization →

Sponsor

Medical University of Graz

Who can join

Adults 18 to 40, female only, with Immune System Tolerance or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interindividual differences in aronia juice tolerability linked to gut microbiome and metabolome changes-secondary analysis of a randomized placebo-controlled parallel intervention trial.
   Lackner S, Mahnert A, Moissl-Eichinger C, Madl T, et al · · 2024 · cited 11× · PMID 38461313 · DOI 10.1186/s40168-024-01774-4
2. Harnessing Nature's Toolbox: Naturally Derived Bioactive Compounds in Nanotechnology Enhanced Formulations.
   Sanjai C, Gaonkar SL, Hakkimane SS. · · 2024 · cited 10× · PMID 39494011 · DOI 10.1021/acsomega.4c07756