Clinical trial NCT04025073: The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome in Individuals With Schizophrenia
Official title: The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome Parameters in Hospitalized Individuals With the Diagnosis of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Schizophrenia
Nutrition Therapy
Lead sponsor: Psychiatric Hospital Ugljan
Sponsor class: INDIV
Collaborators: name: University of Zagreb
First posted: 2019-07-18
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-density lipoprotein cholesterol, and high fasting glucose level. Metabolic syndrome represents one of the major risk factors for the development of cardiovascular diseases and type 2 diabetes mellitus. According to the results of numerous previously conducted studies, the prevalence of metabolic syndrome among the individuals with schizophrenia is higher than in the general population.

The reasons for the higher prevalence of metabolic syndrome among the individuals with schizophrenia are not yet fully clarified. Nevertheless, unhealthy dietary habits are considered to be one of the main factors that could have an impact on metabolic syndrome development. According to the results of published studies, individuals with schizophrenia have poorer dietary habits when compared to people without mental disorders.

Although there are numerous previously published studies focused on the impact of nutritional interventions on metabolic syndrome in individuals with schizophrenia, there is still no consensus on what would be the most appropriate nutrition therapy for the treatment of metabolic syndrome in this specific population group. Furthermore, the vast majority of the published studies have been conducted on outpatients, with only a small number of them being carried out on hospitalized individuals with a diagnosis of schizophrenia.

Dietary Approaches to Stop Hypertension (DASH) diet is primarily intended to those individuals with elevated blood pressure, but according to some authors, it could have beneficial effects in the treatment of the metabolic syndrome as well. DASH diet represents a healthy way of eating with a special emphasis on low-fat dairy products, fruits, vegetables and whole grains, together with an overall reduction in sodium intake.

Therefore, the present study aims to determine the impact of dietary habits and nutrition intervention on metabolic syndrome parameters in hospitalized individuals with the diagnosis of schizophrenia.

The investigators hypothesize that the intervention will result in the improvement in metabolic syndrome parameters, the amelioration in dietary habits, and the reduction in body weight.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in waist circumference
timeFrame: Baseline and after three months
measure: Change in blood pressure
timeFrame: Baseline and after three months
measure: Change in high-density lipoprotein cholesterol
timeFrame: Baseline and after three months
measure: Change in serum triglycerides
timeFrame: Baseline and after three months
measure: Change in fasting blood glucose
timeFrame: Baseline and after three months
Secondary outcomes:
measure: Change in dietary habits
timeFrame: Baseline and after three months
measure: Change in individual food purchase habits
timeFrame: Baseline and after three months
measure: Dietary intake during the intervention
timeFrame: 3 months
measure: Change in participants' mental condition
timeFrame: Baseline and after three months
measure: Change in body weight
timeFrame: Baseline and after three months
measure: Change in body mass index
timeFrame: Baseline and after three months
measure: Change in waist-to-hip ratio
timeFrame: Baseline and after three months
measure: Change in body fat percentage
timeFrame: Baseline and after three months
measure: Change in total cholesterol
timeFrame: Baseline and after three months
measure: Change in low-density lipoprotein cholesterol
timeFrame: Baseline and after three months
Other outcomes:
Locations:
city: Ugljan
country: Croatia
facility: Psychiatric Hospital Ugljan
Study officials:
affiliation: Psychiatric Hospital Ugljan
name: Tamara Sorić, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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