ESAN III - Energy Sensing in Depression Effects of Daucus Carota Subsp. Sativus on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 week 6 (after the intervention) and after a wash-out period at week 12.
研究概览
简要总结
The purpose of this study is to assess the effects of carotenoids from natural carrot juice on the immune system. Therefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as carotenoids in healthy and depressive individuals, to explore their potential use in therapeutic settings. The consumption of natural fruit juices rich in polyphenols and carotenoids serves as a model for a vegetarian diet, due to the increased micronutrient density derived from plant-based foods. The results obtained may provide preliminary explanatory models for the beneficial effects of a vegetarian diet.
It is hypothesized that the consumption of a natural carotenoid-rich juice alters the expression of regulatory T cells-specific immune cells that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, metabolome, and nutritional status are expected.
This study was registered retrospectively (after recruitment had started) 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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Socio-demographic criteria:
- •Gender: female
- •Age: 18-65 years
- •Confirmation of study participation:
- •Received 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
- •Diagnosis confirmed by an experienced psychiatrist
- •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
- •Acute or chronic diseases or infections (including cancer, fever, pneumological or renal disorders, cardiovascular disease, hematopoietic disorders)
- •Digestive disorders (including fructose intolerance, inflammatory bowel disease, irritable bowel syndrome)
- •Treatment that may have influenced the microbiome (including antibiotic or antifungal treatment within the previous two months, and daily or irregular intake of prebiotics or probiotics within the previous two months; the intake of yogurt and dairy products is permitted)
- •History of gastrointestinal surgery (other than appendectomy)
- •Psychiatric disorders (schizophrenia, dementia, bipolar disorder)
- •Pregnancy or breastfeeding
结局指标
主要结局
Change of baseline regulatory T cells (Tregs) at week 6 (after the intervention) and after a wash-out period at week 12.
时间窗: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.
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. 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
- Effect of carotenoid-rich juice consumption on gut microbiota composition, assessed by changes in alpha diversity (Shannon Index) between intervention and control groups.(From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.)
- Change in plasma carotenoid concentration following carotenoid-rich juice consumption, compared between intervention and control groups.(From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.)
- Change in skin carotenoid levels (measured non-invasively), following carotenoid-rich juice consumption, compared between intervention and control groups.(From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.)