ESAN III - Energy Sensing in Depression
NCT06985381 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-06-27
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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