ESAN III - Energy Sensing in Depression

NCT06985381 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-27

No results posted yet for this study

Summary

The purpose of this study is to assess the effects of carotenoids from natural carrot juice on the immune system. Therefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as carotenoids in healthy and depressive individuals, to explore their potential use in therapeutic settings. The consumption of natural fruit juices rich in polyphenols and carotenoids serves as a model for a vegetarian diet, due to the increased micronutrient density derived from plant-based foods. The results obtained may provide preliminary explanatory models for the beneficial effects of a vegetarian diet.

It is hypothesized that the consumption of a natural carotenoid-rich juice alters the expression of regulatory T cells-specific immune cells that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, metabolome, and nutritional status are expected.

This study was registered retrospectively (after recruitment had started) on ClinicalTrials.gov.

Conditions

  • Obesity
  • Gut Microbiota Modulation
  • Immunomodulation

Interventions

OTHER

Carotenoid-rich juice

The intervention is based on the additional consumption of 200 ml natural carotneoid-rich 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

Control

Participants assigned to the control group are asked to drink additional 200ml of water a day to control liquid intake.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Sandra Holasek, Prof · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06985381 on ClinicalTrials.gov