ESAN II - Energy Sensing in Depression

Plain-language summary

This study investigates the relationship between depression and energy sensing, comparing the effect of aronia juice with placebo. It includes women aged 18-40, examining those diagnosed with depression alongside normal-weight and obese groups. The study has no assigned phase and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Medical University of Graz

Intervention

Aronia Juice, Placebo

Start date

2/25/2019

Estimated completion

1/31/2026

Countries

Austria

Related genes

Locations

• Graz, Austria

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Socio-demographic criteria:

   1. Gender: female
   2. Age: 18-40 years
2. Confirmation of the study settings

   1. receives of information on

      * the aims,
      * methods,
      * anticipated benefits,
      * potential risks, and
      * entailed discomforts of the study
   2. signed declaration of consent
3. Subgroup of depressive patients:

   1. diagnosis of depression according to the ICD-10 criteria for depression
   2. diagnosed by an experienced psychiatrist

      * a structured diagnostic interview
      * voluntarily agreement to participate
      * signed informed consent
4. Subgroup of normal weight participants:

   * WHO criteria for normal weight (body mass index (BMI) 18.5-24.99 kg/m2)
5. Subgroup of obese participants

   * WHO criteria for obesity (BMI \< 30.0 kg/m2)

Exclusion Criteria:

1. Formal criteria:

   * lack of informed consent
2. Health criteria

   1. alcohol- or drug abuse
   2. major cognitive deficits (which do not allow adequate testing)

      * according to Mini Mental Status Examination (MMSE) \<20
   3. patients which are currently in the locked ward of the clinic
   4. acute or chronic diseases or infections within the previous two months

      * upper respiratory tract infections
      * fever
      * chronic inflammatory disorders
      * autoimmune-disorders
      * blood diseases
      * mitochondrial diseases
3. Digestive disorders

   1. fructose intolerance
   2. history of digestive diseases such as

      * inflammatory bowel disease
      * irritable bowel syndrome
   3. treatment that may has influenced the microbiome

      * antibiotic or antifungal treatment within the previous two months
      * daily or irregular intake of prebiotics or probiotics within the previous two months (the intake of yoghurt and dairy products are permitted)
   4. history of gastrointestinal surgery (other than appendectomy)
4. Pregnancy and period of breastfeeding