Effects of Aronia Juice on Immune System and Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of polyphenols from natural aronia juice on the immune system in individuals with depression and those who are healthy. It aims to explore how these phytonutrient-rich juices can influence regulatory T cells and potentially improve gut microbiome health. Participants will consume either aronia juice or a placebo, and the study will assess changes in immune response and overall health. The findings may provide insights into the benefits of a vegetarian diet and its effects on mental health.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical Universtiy of Graz
  Graz, Styria, Austria Recruiting

Study contacts

• Principal investigator: Sandra Holasek, Prof. — Medical Universtiy of Graz
• Study coordinator: Sonja Lackner, Dr.
• Email: sonja.lackner@medunigraz.at
• Phone: +43 316 385 711 66

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.