Tests aronia juice effects on the immune system in adults with depression or obesity
Tests aronia berry juice against placebo to see effects on immune cells in adults.
Plain-language title generated from the registry record
Registry title: ESAN II - Energy Sensing in Depression
Key facts
- Where
- Graz, AustriaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Source: NCT05432362, who can take part
Where in Austria
- Medical Universtiy of GrazGraz, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Graz
- Trial code
- NCT05432362
- Record updated
- 27 November 2024
- Original description
The purpose of this study is to assess the effects of polyphenols from natural aronia juice on the immune system.Read full original descriptionShow less
ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.
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.
Inclusion: Socio-demographic criteria:; Gender: female; Age: 18-40 years; Confirmation of the study settings; receives of information on; the aims,; methods,; anticipated benefits,; potential risks, and; entailed discomforts of the study; signed declaration of consent; Subgroup of depressive patients:; diagnosis of depression according to the ICD-10 criteria for depression; diagnosed by an experienced psychiatrist; a structured diagnostic interview; voluntarily agreement to participate; signed informed consent; Subgroup of normal weight participants:; WHO criteria for normal weight (body mass index (BMI) 18.5-24.99 kg/m2); Subgroup of obese participants; WHO criteria for obesity (BMI < 30.0 kg/m2).
Exclusion: Health criteria; alcohol- or drug abuse; major cognitive deficits (which do not allow adequate testing); according to Mini Mental Status Examination (MMSE) <20; patients which are currently in the locked ward of the clinic; acute or chronic diseases or infections within the previous two months; upper respiratory tract infections; fever; chronic inflammatory disorders; autoimmune-disorders; blood diseases; mitochondrial diseases; Digestive disorders; fructose intolerance; history of digestive diseases such as; inflammatory bowel disease; irritable bowel syndrome; treatment that may has influenced the microbiome; antibiotic or antifungal treatment within the previous two months; daily or irregular intake of prebiotics or probiotics within the previous two months (the intake of yoghurt and dairy products are permitted); history of gastrointestinal surgery (other than appendectomy); Formal criteria:; lack of informed consent; Pregnancy and period of breastfeeding.