Actively Recruiting
ESAN II - Energy Sensing in Depression
Led by Medical University of Graz · Updated on 2024-11-27
120
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
ESAN II - Energy Sensing in Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 40 years
- Informed consent given with understanding of study aims, methods, benefits, risks, and discomforts
- Depressive patients diagnosed by an experienced psychiatrist using ICD-10 criteria with signed consent
- Normal weight participants with BMI between 18.5 and 24.99 kg/m2 according to WHO criteria
- Obese participants with BMI of 30.0 kg/m2 or higher according to WHO criteria
You will not qualify if you...
- Lack of informed consent
- Alcohol or drug abuse
- Major cognitive deficits (Mini Mental Status Examination score less than 20)
- Current hospitalization in a locked clinic ward
- Acute or chronic diseases or infections within the past two months, including upper respiratory infections, fever, chronic inflammatory or autoimmune disorders, blood or mitochondrial diseases
- Fructose intolerance
- History of digestive diseases such as inflammatory bowel disease or irritable bowel syndrome
- Antibiotic or antifungal treatments within the previous two months
- Daily or irregular intake of prebiotics or probiotics within the previous two months (yoghurt and dairy products allowed)
- History of gastrointestinal surgery other than appendectomy
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical Universtiy of Graz
Graz, Styria, Austria, 8010
Actively Recruiting
Research Team
S
Sonja Lackner, Dr.
CONTACT
S
Sandra Holasek, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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