Active — Not RecruitingNot Applicable

ESAN III - Energy Sensing in Depression

Austria120 participantsStarted 2024-03-13

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From enrollment (baseline) to the end of intervention at week 6 and after a wash-out period at week 12.

Trial details

NCT IDNCT06985381

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01

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