ESAN II - Energy Sensing in Depression

Medical University of Graz

Status: Enrolling

Conditions: Immune System Tolerance; Microbial Colonization; Obesity; Depression; Diet, Healthy

Treatments: Other: Aronia Juice; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05432362

ESANII

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 6 patient groups, including a placebo group

Verum Normal Weight

Experimental group

Description:

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.

Treatment:

Other: Aronia Juice

Verum Obesity

Experimental group

Description:

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.

Treatment:

Other: Aronia Juice

Verum Depression

Experimental group

Description:

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.

Treatment:

Other: Aronia Juice

Placebo Normal Weight

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Placebo Obesity

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Placebo Depression

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo