Status:
COMPLETED
The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome in Individuals With Schizophrenia
Lead Sponsor:
Tamara Sorić
Collaborating Sponsors:
University of Zagreb
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-67 years
Phase:
NA
Brief Summary
Metabolic syndrome is a term used to describe a complex clinical condition that includes abdominal obesity, increased level of serum triglycerides, elevated blood pressure, decreased level of high-den...
Eligibility Criteria
Inclusion
- the diagnosis of schizophrenia according to the 10th Revision of the International Classification of Diseases (ICD-10)
- age 18-67
- the diagnosis of metabolic syndrome according to the Joint Interim Statement definition
- taking antipsychotic medication for the last 6 months or more
- a stable phase of schizophrenia
- provided written informed consent (for participants deprived of legal capacity, provided written informed consent of both the participants and their legal guardians)
Exclusion
- older than 67
- without the diagnosis of schizophrenia and/or metabolic syndrome
- following one of the specific hospital diets with the restrictions related to the intake of specific food items, groups or nutrients
- taking medications for the reduction of body weight
- significant body weight loss in the past 3 months
- refusing to provide written informed consent
- on personal request
- deterioration in participant's mental state
- the occurrence of a new illness that could unable full participation in the study or could have an interfering effect
- a significant change in pharmacological therapy during the intervention period
- cognitive impairments that unable full participation in the study
- lack of interest or refusal to fully participate in the study
- hospital discharge during the intervention period
Key Trial Info
Start Date :
May 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2017
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04025073
Start Date
May 2 2017
End Date
December 20 2017
Last Update
July 18 2019
Active Locations (1)
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1
Psychiatric Hospital Ugljan
Ugljan, Croatia, 23275