Back to resultsESAN II - Energy Sensing in Depression
Primary Purpose
Immune System Tolerance, Depression, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Aronia Juice
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Immune System Tolerance focused on measuring polyphenols, Aronia melanocarpa, immunomodulation, plant based food, natural food
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Formal criteria:
- lack of informed consent
Health criteria
- alcohol- or drug abuse
major cognitive deficits (which do not allow adequate testing)
- according to Mini Mental Status Examination (MMSE) <20
- patients which are currently in the locked ward of the clinic
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
Digestive disorders
- fructose intolerance
history of digestive diseases such as
- inflammatory bowel disease
- irritable bowel syndrome
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)
- history of gastrointestinal surgery (other than appendectomy)
- Pregnancy and period of breastfeeding
Sites / Locations
- Medical Universtiy of GrazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Verum Normal Weight
Verum Obesity
Verum Depression
Placebo Normal Weight
Placebo Obesity
Placebo Depression
Arm 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.
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.
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.
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.
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
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
Outcomes
Primary Outcome Measures
Change of baseline regulatory T cells (Tregs) at 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)
Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. The assessment of Trges after 12 weeks aims to identify any persisting effects of the intervention.
Secondary Outcome Measures
Change of baseline gut microbiome at 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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05432362
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 immunesystem 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Tolerance, Depression, Obesity, Microbial Colonization, Diet, Healthy
Keywords
polyphenols, Aronia melanocarpa, immunomodulation, plant based food, natural food
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Participant
Masking Description
The randomizer (online tool of the Medical University of Graz) will be used for randomisation of group assignment. The two juices are provided in the same containers.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verum Normal Weight
Arm Type
Experimental
Arm 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.
Arm Title
Verum Obesity
Arm Type
Experimental
Arm 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.
Arm Title
Verum Depression
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Normal Weight
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Placebo Obesity
Arm Type
Placebo Comparator
Arm 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
Arm Title
Placebo Depression
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Aronia Juice
Intervention Description
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 availabe juice in addition to their regular diet. Further, they are asked not to change their diets and lifestyle behaviour during the intervention.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention)
Description
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.
Time Frame
Determination at baseline (day 0) and after 6 weeks (after the intervention)
Title
Change of baseline regulatory T cells (Tregs) at 12 weeks (after the intervention and another 6 weeks of wash out)
Description
Tregs are involved in modulating the immune system and maintaining tolerance to self-antigens and preventing autoimmune diseases. The assessment of Trges after 12 weeks aims to identify any persisting effects of the intervention.
Time Frame
Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Secondary Outcome Measure Information:
Title
Change of baseline gut microbiome at 6 weeks (after the intervention)
Description
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.
Time Frame
Determination at baseline (day 0) and after 6 weeks (after the intervention)
Title
Change of baseline gut microbiome at 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Description
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.
Time Frame
Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
Other Pre-specified Outcome Measures:
Title
Change of baseline metabolome at 6 weeks (after the intervention)
Description
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.
Time Frame
Determination at baseline (day 0) and after 6 weeks (after the intervention)
Title
Change of baseline metabolome at 12 weeks (after the 6 weeks intervention and another 6 weeks of wash out)
Description
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.
Time Frame
Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Formal criteria:
lack of informed consent
Health criteria
alcohol- or drug abuse
major cognitive deficits (which do not allow adequate testing)
according to Mini Mental Status Examination (MMSE) <20
patients which are currently in the locked ward of the clinic
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
Digestive disorders
fructose intolerance
history of digestive diseases such as
inflammatory bowel disease
irritable bowel syndrome
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)
history of gastrointestinal surgery (other than appendectomy)
Pregnancy and period of breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Lackner, Dr.
Phone
+43 316 385 711 66
Email
sonja.lackner@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Holasek, Prof.
Phone
+43 316 385 71153
Email
sandra.holasek@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Holasek, Prof.
Organizational Affiliation
Medical Universtiy of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Universtiy of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8010
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonja Lackner, Dr.
Phone
+43 316 385 71166
Email
sonja.lackner@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Sandra Holasek, Prof.
Phone
+43 316 385 71153
Email
sandra.holasek@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Theresa Lahousen, Dr.
First Name & Middle Initial & Last Name & Degree
Sabrina Mörkl, DDr.
First Name & Middle Initial & Last Name & Degree
Sonja Lackner, Dr.
12. IPD Sharing Statement
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ESAN II - Energy Sensing in Depression
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