ESAN II - Energy Sensing in Depression

Not Applicable

Recruiting

• Conditions: Depression; Diet, Healthy; Immune System Tolerance; Microbial Colonization; Obesity
• Interventions: Other: Aronia Juice; Other: Placebo

• Registration Number: NCT05432362
• Lead Sponsor: Medical University of Graz

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-25
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum Normal Weight	Aronia Juice	Normal weight participants receiving polyphenol-rich Aronia juice (verum) (n=20) The aronia juice is derived from a local producer, a common food and commercially available.
Placebo Normal Weight	Placebo	Normal weight participants receiving placebo (control) (n=20) The placebo drink is prepared according to a published recipe and contains nutrients such as sugars, vitamins and minerals. It has a comparable nutrients profile as the aronia juice but is completely polyphenol-free.
Placebo Obesity	Placebo	Obese participants receiving placebo (control) (n=20) The placebo drink is prepared according to a published recipe and contains nutrients such as sugars, vitamins and minerals. It has a comparable nutrients profile as the aronia juice but is completely polyphenol-free
Verum Obesity	Aronia Juice	Adipose participants receiving polyphenol-rich Aronia juice (verum) (n=20) The aronia juice is derived from a local producer, a common food and commercially available.
Verum Depression	Aronia Juice	Depressive participants receiving polyphenol-rich Aronia juice (verum) (n=20) The aronia juice is derived from a local producer, a common food and commercially available.
Placebo Depression	Placebo	Depressive participants receiving placebo (control) (n=20) The placebo drink is prepared according to a published recipe and contains nutrients such as sugars, vitamins and minerals. It has a comparable nutrients profile as the aronia juice but is completely polyphenol-free

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change of baseline gut microbiome at 6 weeks (after the intervention)	Determination at baseline (day 0) and after 6 weeks (after the intervention)	Stool samples will be collected with the PSP spin stool DNA stool collection kit (Stratec, Birkenfeld, GER) and processed according to the suppliers recommendations. Subsequently to DNA extraction the variable V1-V2 region of the bacterial 16S rRNA gene is amplified with PCR using oligonucleotide primers BSF8 and BSR357.
Change of baseline gut microbiome at 12 weeks (after the 6-weeks 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)	Stool samples will be collected with the PSP spin stool DNA stool collection kit (Stratec, Birkenfeld, GER) and processed according to the suppliers recommendations. Subsequently to DNA extraction the variable V1-V2 region of the bacterial 16S rRNA gene is amplified with PCR using oligonucleotide primers BSF8 and BSR357. The assessment of the change in the gut microbiome after 12 weeks aims to identify any persisting effects of the intervention.

Trial Locations

Locations (1)

Medical Universtiy of Graz; 🇦🇹 Graz, Styria, Austria