ESAN II - Energy Sensing in Depression

November 25, 2024 updated by: Medical University of Graz

ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • Recruiting
        • Medical Universtiy of Graz
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Theresa Lahousen, Dr.
        • Sub-Investigator:
          • Sabrina Mörkl, DDr.
        • Sub-Investigator:
          • Sonja Lackner, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Verum Normal Weight
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.
Other: Aronia Juice
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.
Experimental: Verum Obesity
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.
Other: Aronia Juice
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.
Experimental: Verum Depression
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.
Other: Aronia Juice
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 Comparator: Placebo Normal Weight

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.
Other: Placebo
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.
Placebo Comparator: Placebo Obesity

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
Other: Placebo
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.
Placebo Comparator: Placebo Depression

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
Other: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention)
Time Frame: 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.
Determination at baseline (day 0) and after 6 weeks (after the intervention)
Change of baseline regulatory T cells (Tregs) at 12 weeks (after the intervention and another 6 weeks of wash out)
Time Frame: 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.
Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of baseline gut microbiome at 6 weeks (after the intervention)
Time Frame: 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.
Determination at baseline (day 0) and after 6 weeks (after the intervention)
Change of baseline gut microbiome at 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Time Frame: 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.
Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of baseline metabolome at 6 weeks (after the intervention)
Time Frame: Determination at baseline (day 0) and after 6 weeks (after the intervention)
The metabolome can be identified in various biological materials such as blood (EDTA and serum) Metabolites in blood will be analyzed by using 1H-NMR spectra. A non-targeted approach will be applied to characterize a potential shift in the participants' metabolic profile.
Determination at baseline (day 0) and after 6 weeks (after the intervention)
Change of baseline metabolome at 12 weeks (after the 6 weeks intervention and another 6 weeks of wash out)
Time Frame: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
The metabolome can be identified in various biological materials such as blood (EDTA and serum) Metabolites in blood will be analyzed by using 1H-NMR spectra. A non-targeted approach will be applied to characterize a potential shift in the participants' metabolic profile.The assessment of the change in the metabolome after 12 weeks aims to identify any persisting effects of the intervention.
Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Sandra Holasek, Prof., Medical Universtiy of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESANII

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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