Clinical trial

ESAN II - Energy Sensing in Depression

Recruiting now · Not applicable · 1 countries · Registry ID NCT05432362

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 40 Years

SexFemale

Healthy volunteersAccepted

ConditionImmune System Tolerance, Depression, Obesity, Microbial Colonization, Diet, Healthy

Full registry 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

Treatments and study arms

Aronia Juice

Other

The intervention is based an the additional consumption of 200 ml natural juice a day for a period of six weeks. The participants are asked to drink the natural and commercially available juice in addition to their regular diet. Further, they are asked not to change their diets and lifestyle behaviour during the intervention.

Placebo

Other

A beverage is prepared according to a known recipe. It contains macro- and micronutrients in comparable amounts like the aronia juice. It is completely polyphenol free.

Primary outcomes

Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention)Determination at baseline (day 0) and after 6 weeks (after the intervention)

Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. Regulatory T cells (Treg) will be quantified using multiparameter flow cytometry. Monoclonal antibodies specific for surface markers such as CD3, CD4, CD45RA, CD39 and CD25 will be combined with intracellular anti-Foxp3 for the identification of human Treg.

Change of baseline regulatory T cells (Tregs) at 12 weeks (after the intervention and another 6 weeks of wash out)Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)

Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. The assessment of Tregs after 12 weeks aims to identify any persisting effects of the intervention.

Study locations

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Medical Universtiy of Graz🇦🇹 Graz, Styria, Austria

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Sonja Lackner, Dr.Contact

Email · Call +43 316 385 71166

Sandra Holasek, Prof.Contact

Email · Call +43 316 385 71153

Theresa Lahousen, Dr.Sub Investigator