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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• Socio-demographic criteria:

‣ Gender: female

⁃ Age: 18-40 years

• Confirmation of the study settings

‣ receives of information on

• the aims,

∙ methods,

∙ anticipated benefits,

∙ potential risks, and

∙ entailed discomforts of the study

⁃ signed declaration of consent

• Subgroup of depressive patients:

‣ diagnosis of depression according to the ICD-10 criteria for depression

⁃ diagnosed by an experienced psychiatrist

• a structured diagnostic interview

∙ voluntarily agreement to participate

∙ signed informed consent

• Subgroup of normal weight participants:

⁃ WHO criteria for normal weight (body mass index (BMI) 18.5-24.99 kg/m2)

• Subgroup of obese participants

⁃ WHO criteria for obesity (BMI \< 30.0 kg/m2)

Locations
Other Locations
Austria
Medical Universtiy of Graz
RECRUITING
Graz
Contact Information
Primary
Sonja Lackner, Dr.
sonja.lackner@medunigraz.at
+43 316 385 711 66
Backup
Sandra Holasek, Prof.
sandra.holasek@medunigraz.at
+43 316 385 71153
Time Frame
Start Date: 2019-02-25
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 120
Treatments
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.
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.
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.
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.
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
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
Related Therapeutic Areas
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov