Status:

ACTIVE_NOT_RECRUITING

ESAN III - Energy Sensing in Depression

Lead Sponsor:

Medical University of Graz

Conditions:

Obesity

Gut Microbiota Modulation

Eligibility:

FEMALE

18-65 years

Phase:

NA

Brief 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 i...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 13 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2026

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT06985381

    Start Date

    March 13 2024

    End Date

    January 1 2026

    Last Update

    June 27 2025

    Active Locations (1)

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    Medical Universtiy of Graz

    Graz, Styria, Austria, 8010