ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Socio-demographic criteria:
- •Gender: female
- •Age: 18-40 years
- •Confirmation of the study settings
- •receives of information on
- •the aims,
- •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)
排除标准
- •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
- •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
结局指标
主要结局
Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention)
时间窗: 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)
时间窗: 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.
次要结局
- Change of baseline gut microbiome at 6 weeks (after the intervention)(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)(Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out))