ESAN II - Energy Sensing in Depression

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention) [Срок оценки: 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) [Срок оценки: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)]

Вторичные конечные точки (2)

• Change of baseline gut microbiome at 6 weeks (after the intervention) [Срок оценки: 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) [Срок оценки: Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Австрия · 1 центр

• Medical Universtiy of Graz — Graz

Публикации

• 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. PMID 28438331
• 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. PMID 28654462
• 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. PMID 26527507
• 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. PMID 28053336
• 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. PMID 28285098
• 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. PMID 16648838
• Kim W, Lee H. Advances in nutritional research on regulatory T-cells. Nutrients. 2013 Oct 28;5(11):4305-15. doi: 10.3390/nu5114305. PMID 24169507
• 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. PMID 25845339

Идентификаторы

NCT: NCT05432362 · ESANII

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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