Status:

COMPLETED

The Evaluation of the Efficacy of a Fasting Mimicking Diet Added to Functional Therapy for Depression

Lead Sponsor:

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Collaborating Sponsors:

University of Palermo

Centro Studi Psicoterapia Neo-Funzionale

Conditions:

Depression

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

Depression has to be considered as a systematic illness involving the whole body, it is often associated with low-grade inflammation and alterations of the microbiome. In this regard, an unhealthy die...

Detailed Description

Depression is considered as a systemic illness affecting the whole body and increasing the risk of several diseases. Several studies showed an important link between depression and inflammation. Indee...

Eligibility Criteria

Inclusion

  • a score at the Beck Depression Inventory - II (BDI-II) over than 13 at the time of initial assessment;
  • age from 18 to 60 years old;
  • seeking treatment for mood problems;
  • not involved in a concurrent treatment;
  • without any psychopharmacological treatment for depression in the previous 12 months;
  • without any practice of yoga or meditation;

Exclusion

  • a current or lifetime diagnosis of psychotic disorders, borderline, schizotypal, or antisocial personality disorder, active suicidal ideation with a plan, eating disorders, bipolar disorder, primary anxiety disorder
  • a past or present of drug abuse or drug addiction (excluding nicotine)
  • chronic inflammation diseases
  • eating disorders
  • IQ less than 65
  • BMI less than 18.5 or more than 30
  • severe hepatic failure
  • serious infections (such as HIV, hepatitis B and C)
  • cancer in the previous 6 months
  • regular use of anti-inflammatory drugs for more than 15 days/month

Key Trial Info

Start Date :

September 12 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 27 2019

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04050475

Start Date

September 12 2018

End Date

June 27 2019

Last Update

August 9 2019

Active Locations (1)

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1

Unit of Psychiatry

Palermo, Italy, 90100