NCT06985381Active, not recruiting
ESAN III - Energy Sensing in Depression
ESAN III - Energy Sensing in Depression Effects of Daucus Carota Subsp. Sativus on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 2 May 2025
- Start date
- 13 Mar 2024
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Medical University of Graz
- Diseases
- Obesity
- NCT number
- NCT06985381
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 13 Mar 2024 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or drug abuse
- 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)
Other illness
- 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)
- History of gastrointestinal surgery (other than appendectomy)
- Psychiatric disorders (schizophrenia, dementia, bipolar disorder)
Other
- Formal criteria:
- Lack of informed consent
- Health criteria:
- Pregnancy or breastfeeding
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Universtiy of Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.