Status:
RECRUITING
ESAN II - Energy Sensing in Depression
Lead Sponsor:
Medical University of Graz
Conditions:
Immune System Tolerance
Depression
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
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
- Formal criteria:
- lack of informed consent
- 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)
- Pregnancy and period of breastfeeding
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05432362
Start Date
February 25 2019
End Date
January 31 2026
Last Update
November 27 2024
Active Locations (1)
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1
Medical Universtiy of Graz
Graz, Styria, Austria, 8010