NCT05432362Recruiting
ESAN II - Energy Sensing in Depression
ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 13 Jun 2022
- Start date
- 25 Feb 2019
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Medical University of Graz
- Diseases
- Obesity
- NCT number
- NCT05432362
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 25 Feb 2019 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- Formal criteria:
- lack of informed consent
- Pregnancy and period of breastfeeding
Who the study is looking for
- 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)
Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Universtiy of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.