Clinical trial NCT05432362: ESAN II - Energy Sensing in Depression
Official title: ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immune System Tolerance
Depression
Obesity
Microbial Colonization
Diet, Healthy
Keywords: polyphenols
Aronia melanocarpa
immunomodulation
plant based food
natural food
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This monocentric study is a food product study (comparison between in trade available polyphenol-rich juice and a placebo).

Aronia juice is a locally produced, commercially available natural source of various secondary plant nutrients. It naturally contains high amounts of polyphenols. The placebo juice is prepared according to a published recipe and contains comparable amounts of nutrients such as vitamins and minerals but is totally polyphenol-free.

Six study groups are designated:

Group VN = normal weight participants receiving polyphenol-rich juice (verum) (n=20) Group VA = adipose participants receiving polyphenol-rich juice (verum) (n=20) Group VD = depressive patients receiving polyphenol-rich juice (verum) (n=20) Group CN = normal weight participants receiving placebo (control) (n=20) Group CA = adipose participants receiving placebo (control) (n=20) Group CD = depressive patients receiving placebo (control) (n=20)
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention)
timeFrame: Determination at baseline (day 0) and after 6 weeks (after the intervention)
measure: Change of baseline regulatory T cells (Tregs) at 12 weeks (after the intervention and another 6 weeks of wash out)
timeFrame: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Secondary outcomes:
measure: Change of baseline gut microbiome at 6 weeks (after the intervention)
timeFrame: Determination at baseline (day 0) and after 6 weeks (after the intervention)
measure: Change of baseline gut microbiome at 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
timeFrame: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Other outcomes:
measure: Change of baseline metabolome at 6 weeks (after the intervention)
timeFrame: Determination at baseline (day 0) and after 6 weeks (after the intervention)
measure: Change of baseline metabolome at 12 weeks (after the 6 weeks intervention and another 6 weeks of wash out)
timeFrame: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Locations:
city: Graz
country: Austria
facility: Medical Universtiy of Graz
state: Styria
Study officials:
affiliation: Medical Universtiy of Graz
name: Sandra Holasek, Prof.
role: PRINCIPAL_INVESTIGATOR
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