ESAN II - Energy Sensing in Depression

Launched by MEDICAL UNIVERSITY OF GRAZ · Jun 20, 2022

Keywords

ClinConnect Summary

The ESAN II clinical trial is studying how drinking aronia juice, which is packed with healthy plant compounds called polyphenols, can affect the immune system and overall health in women aged 18 to 40. The researchers want to see if this juice can help improve immune functions and create positive changes in gut health, especially for women dealing with depression or those who are obese. By understanding these effects, the study hopes to explore the potential benefits of a diet rich in natural plant foods.

To participate in this study, women must meet certain criteria, such as being between 18 and 40 years old and having a diagnosis of depression or being classified as normal weight or obese based on specific guidelines. Participants will receive detailed information about the study and will need to provide consent. Those who join can expect to learn more about how their diet may influence their health and mood through the consumption of aronia juice. It’s important to note that some health conditions or treatments may exclude individuals from participating in the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 1. Socio-demographic criteria:
• • 1. Gender: female
• • 2. Age: 18-40 years
• • 2. Confirmation of the study settings
• • 1. receives of information on
• • the aims,
• • methods,
• • anticipated benefits,
• • potential risks, and
• • entailed discomforts of the study
• • 2. signed declaration of consent
• 3. Subgroup of depressive patients:
• • 1. diagnosis of depression according to the ICD-10 criteria for depression
• • 2. diagnosed by an experienced psychiatrist
• • a structured diagnostic interview
• • voluntarily agreement to participate
• • signed informed consent
• 4. Subgroup of normal weight participants:
• • WHO criteria for normal weight (body mass index (BMI) 18.5-24.99 kg/m2)
• • 5. Subgroup of obese participants
• • WHO criteria for obesity (BMI \< 30.0 kg/m2)
• Exclusion Criteria:
• 1. Formal criteria:
• • lack of informed consent
• • 2. Health criteria
• • 1. alcohol- or drug abuse
• • 2. major cognitive deficits (which do not allow adequate testing)
• • according to Mini Mental Status Examination (MMSE) \<20
• • 3. patients which are currently in the locked ward of the clinic
• • 4. 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
• • 3. Digestive disorders
• • 1. fructose intolerance
• • 2. history of digestive diseases such as
• • inflammatory bowel disease
• • irritable bowel syndrome
• • 3. 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)
• • 4. history of gastrointestinal surgery (other than appendectomy)
• • 4. Pregnancy and period of breastfeeding