Clinical trial

ESAN III - Energy Sensing in Depression

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06985381

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexFemale

Healthy volunteersAccepted

ConditionObesity, Gut Microbiota Modulation, Immunomodulation

Full registry criteria

INCLUSION CRITERIA 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) EXCLUSION CRITERIA 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

Treatments and study arms

Carotenoid-rich juice

Other

The intervention is based on the additional consumption of 200 ml natural carotneoid-rich 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.

Control

Other

Participants assigned to the control group are asked to drink additional 200ml of water a day to control liquid intake.

Primary outcomes

Change of baseline regulatory T cells (Tregs) at week 6 (after the intervention) and after a wash-out period at week 12.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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Medical Universtiy of Graz🇦🇹 Graz, Styria, Austria

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