Depression, Diet, Healthy, Immune System Tolerance, Microbial Colonization, Obesity
Conditions
Keywords
polyphenols, Aronia melanocarpa, immunomodulation, plant based food, natural food
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.
Interventions
OTHERAronia 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.
OTHERPlacebo
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.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
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)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention) | 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. |
| Change of baseline regulatory T cells (Tregs) at 12 weeks (after the intervention and another 6 weeks of wash out) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of baseline gut microbiome at 6 weeks (after the intervention) | 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. |
| Change of baseline gut microbiome at 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of baseline metabolome at 6 weeks (after the intervention) | 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. |
| Change of baseline metabolome at 12 weeks (after the 6 weeks intervention and another 6 weeks of wash out) | 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. |
Countries
Austria
Contacts
Primary ContactSonja Lackner, Dr.
Backup ContactSandra Holasek, Prof.
Outcome results
None listed