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NCT Number: NCT04025073

The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome in Individuals With Schizophrenia

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric Hospital Ugljan

Ugljan, 23275, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Approaches to Stop Hypertension

Other

The DASH diet will have a reduced caloric intake by 400 kcal/day, when compared to the standard hospital diet. The DASH diet will be planned according to the following: total daily energy intake 1,900 kcal; total daily fat intake 27%; daily intake of saturated fatty acids 6%; total daily protein intake 18%; total daily carbohydrates intake 55%; cholesterol 150 mg/day; sodium 2,300 mg/day; potassium 4,700 mg/day; calcium 1,250 mg/day; magnesium 500 mg/day; and fiber 30 g/day.

Other names: DASH diet

Nutrition Education Program

Other

The nutrition education program will consist of four lectures intended to improve the overall participants' dietary habits. The lectures will be interactive and will be organized in smaller groups (up to 10 participants) covering the following themes: My Plate dietary guidelines; Principles of a balanced diet; Reading and understanding food nutrition labels; Dietary recommendations for elevated blood pressure, dyslipidemia, and diabetes mellitus.

Primary outcomes

  1. Change in waist circumference

    Time frame: Baseline and after three months

    Waist circumference measuring (in cm) will be performed prior to and immediately after the intervention using a non-strechable measuring tape.

  2. Change in blood pressure

    Time frame: Baseline and after three months

    The assessment of blood pressure (in mmHg) will be performed prior to and immediately after the intervention using an aneroid blood pressure gauge.

  3. Change in high-density lipoprotein cholesterol

    Time frame: Baseline and after three months

    The blood serum concentration of high-density lipoprotein cholesterol (in mmol/L) will be determined prior to and immediately after the intervention. Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas c 111 analyzer.

  4. Change in serum triglycerides

    Time frame: Baseline and after three months

    The concentration of serum triglycerides (in mmol/L) will be determined prior to and immediately after the intervention. Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas c 111 analyzer.

  5. Change in fasting blood glucose

    Time frame: Baseline and after three months

    The blood serum concentration of glucose (in mmol/L) will be determined prior to and immediately after the intervention. Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas c 111 analyzer.

Secondary outcomes

  1. Change in dietary habits

    Time frame: Baseline and after three months

    Dietary habits will be assessed using the nutrition section of Dlugosch & Krieger's General Health Behavior Questionnaire both prior to and immediately after the intervention.

  2. Change in individual food purchase habits

    Time frame: Baseline and after three months

    Individual food purchase diaries, collected at the beginning and at the end of the intervention period, will be used for the evaluation of the changes in individual food purchase habits.

  3. Dietary intake during the intervention

    Time frame: 3 months

    Dietary intake during the intervention will be assessed using three non-consecutive 24-hour dietary recalls (two weekdays and one weekend day).

  4. Change in participants' mental condition

    Time frame: Baseline and after three months

    The global severity of the psychotic illness and severity of specific syndromes within psychotic illness will be evaluated prior to and immediately after the intervention using Signs and Symptoms of Psychotic Illness (SSPI) scale. The scale consists of 20 items (signs and symptoms of psychotic illness). For each item (subscale) a score in the range 0 - 4 is assigned: 0 - no psychopatology; 1 - a deviation questionably pathological; 2 - mild pathological deviation; 3 - pathology of moderate severity; 4 - severe psychopathology. Subscales are summed to determine a global severity of psychotic illness. The highest total score is 80.

  5. Change in body weight

    Time frame: Baseline and after three months

    Body weight (in kg) will be measured prior to and immediately after the intervention using a digital medical scale witl stadiometer.

  6. Change in body mass index

    Time frame: Baseline and after three months

    The measured values of body height and weight will be used for the calculation of body mass index (in kg/m^2).

  7. Change in waist-to-hip ratio

    Time frame: Baseline and after three months

    The waist-to-hip ratio will be calculated from the measured values of waist and hip circumferences: waist circumference (cm) / hip circumference (cm).

  8. Change in body fat percentage

    Time frame: Baseline and after three months

    Determination of body fat percentage will be performed using OMRON BF500 analyzer.

  9. Change in total cholesterol

    Time frame: Baseline and after three months

    The concentration of total cholesterol (in mmol/L) will be determined prior to and immediately after the intervention. Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas c 111 analyzer.

  10. Change in low-density lipoprotein cholesterol

    Time frame: Baseline and after three months

    The concentration of low-density lipoprotein cholesterol (in mmol/L) will be determined prior to and immediately after the intervention. Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas c 111 analyzer.

Sponsors and collaborators

Lead sponsor

Tamara Sorić

Indiv

Collaborators

  • University of Zagreb

Registry information

Official study title

The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome Parameters in Hospitalized Individuals With the Diagnosis of Schizophrenia

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2019
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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