Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2019-02-25
2026-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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)
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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 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
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 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
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 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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Sandra Holasek, Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical Universtiy of Graz
Locations
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Medical Universtiy of Graz
Graz, Styria, Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Meyrel M, Varin L, Detaint B, Mouaffak F. [The intestinal microbiota: A new player in depression?]. Encephale. 2018 Feb;44(1):67-74. doi: 10.1016/j.encep.2017.03.005. Epub 2017 Apr 24. French.
Koopman M, El Aidy S; MIDtrauma consortium. Depressed gut? The microbiota-diet-inflammation trialogue in depression. Curr Opin Psychiatry. 2017 Sep;30(5):369-377. doi: 10.1097/YCO.0000000000000350.
De Rosa V, Galgani M, Santopaolo M, Colamatteo A, Laccetti R, Matarese G. Nutritional control of immunity: Balancing the metabolic requirements with an appropriate immune function. Semin Immunol. 2015 Sep;27(5):300-9. doi: 10.1016/j.smim.2015.10.001. Epub 2015 Oct 29.
Abella V, Scotece M, Conde J, Pino J, Gonzalez-Gay MA, Gomez-Reino JJ, Mera A, Lago F, Gomez R, Gualillo O. Leptin in the interplay of inflammation, metabolism and immune system disorders. Nat Rev Rheumatol. 2017 Feb;13(2):100-109. doi: 10.1038/nrrheum.2016.209. Epub 2017 Jan 5.
Perez-Perez A, Vilarino-Garcia T, Fernandez-Riejos P, Martin-Gonzalez J, Segura-Egea JJ, Sanchez-Margalet V. Role of leptin as a link between metabolism and the immune system. Cytokine Growth Factor Rev. 2017 Jun;35:71-84. doi: 10.1016/j.cytogfr.2017.03.001. Epub 2017 Mar 4.
Bettelli E, Carrier Y, Gao W, Korn T, Strom TB, Oukka M, Weiner HL, Kuchroo VK. Reciprocal developmental pathways for the generation of pathogenic effector TH17 and regulatory T cells. Nature. 2006 May 11;441(7090):235-8. doi: 10.1038/nature04753. Epub 2006 Apr 30.
Kim W, Lee H. Advances in nutritional research on regulatory T-cells. Nutrients. 2013 Oct 28;5(11):4305-15. doi: 10.3390/nu5114305.
Kim YS, Sayers TJ, Colburn NH, Milner JA, Young HA. Impact of dietary components on NK and Treg cell function for cancer prevention. Mol Carcinog. 2015 Sep;54(9):669-78. doi: 10.1002/mc.22301. Epub 2015 Apr 1.
Xue Z, Li D, Yu W, Zhang Q, Hou X, He Y, Kou X. Mechanisms and therapeutic prospects of polyphenols as modulators of the aryl hydrocarbon receptor. Food Funct. 2017 Apr 19;8(4):1414-1437. doi: 10.1039/c6fo01810f.
Shanahan F, van Sinderen D, O'Toole PW, Stanton C. Feeding the microbiota: transducer of nutrient signals for the host. Gut. 2017 Sep;66(9):1709-1717. doi: 10.1136/gutjnl-2017-313872. Epub 2017 Jun 29.
Vauzour D, Rodriguez-Mateos A, Corona G, Oruna-Concha MJ, Spencer JP. Polyphenols and human health: prevention of disease and mechanisms of action. Nutrients. 2010 Nov;2(11):1106-31. doi: 10.3390/nu2111106. Epub 2010 Nov 8.
Mullan A, Delles C, Ferrell W, Mullen W, Edwards CA, McColl JH, Roberts SA, Lean ME, Sattar N. Effects of a beverage rich in (poly)phenols on established and novel risk markers for vascular disease in medically uncomplicated overweight or obese subjects: A four week randomized placebo-controlled trial. Atherosclerosis. 2016 Mar;246:169-76. doi: 10.1016/j.atherosclerosis.2016.01.004. Epub 2016 Jan 6.
Aguirre L, Fernandez-Quintela A, Arias N, Portillo MP. Resveratrol: anti-obesity mechanisms of action. Molecules. 2014 Nov 14;19(11):18632-55. doi: 10.3390/molecules191118632.
Chrubasik C, Li G, Chrubasik S. The clinical effectiveness of chokeberry: a systematic review. Phytother Res. 2010 Aug;24(8):1107-14. doi: 10.1002/ptr.3226.
Morkl S, Lackner S, Muller W, Gorkiewicz G, Kashofer K, Oberascher A, Painold A, Holl A, Holzer P, Meinitzer A, Mangge H, Holasek S. Gut microbiota and body composition in anorexia nervosa inpatients in comparison to athletes, overweight, obese, and normal weight controls. Int J Eat Disord. 2017 Dec;50(12):1421-1431. doi: 10.1002/eat.22801. Epub 2017 Nov 13.
Lackner S, Mahnert A, Moissl-Eichinger C, Madl T, Habisch H, Meier-Allard N, Kumpitsch C, Lahousen T, Kohlhammer-Dohr A, Morkl S, Strobl H, Holasek S. Interindividual differences in aronia juice tolerability linked to gut microbiome and metabolome changes-secondary analysis of a randomized placebo-controlled parallel intervention trial. Microbiome. 2024 Mar 9;12(1):49. doi: 10.1186/s40168-024-01774-4.
Other Identifiers
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ESANII
Identifier Type: -
Identifier Source: org_study_id