Effects of Aronia Juice on Immune System and Depression
ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.
This study is testing whether drinking aronia juice can boost the immune system and help people with depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT05432362 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include females aged 18-40 with a diagnosis of depression or those classified as normal weight or obese according to WHO criteria.
Not a fit: Patients with alcohol or drug abuse issues or major cognitive deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a natural dietary intervention for improving immune function and alleviating symptoms of depression.
How similar studies have performed: While the specific approach of using aronia juice is novel, other studies have shown positive effects of polyphenol-rich diets on health outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz, Styria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.