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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metabolic Syndrome | Other: Dietary Approaches to Stop Hypertension Other: Nutrition education program | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 79 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome Parameters in Hospitalized Individuals With the Diagnosis of Schizophrenia |
| Actual Study Start Date : | May 2, 2017 |
| Actual Primary Completion Date : | December 20, 2017 |
| Actual Study Completion Date : | December 20, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention Group
The intervention group will be assigned to the DASH diet with moderately reduced caloric intake and will participate in a nutrition education program.
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Other: Dietary Approaches to Stop Hypertension
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 Name: DASH diet
Other: Nutrition education program 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.
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Experimental: Control Group
The control group will continue to follow the standard hospital diet and will participate in the same nutrition education program as the intervention group.
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Other: Nutrition education program
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.
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| Ages Eligible for Study: | 18 Years to 67 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Croatia | |
| Psychiatric Hospital Ugljan | |
| Ugljan, Croatia, 23275 | |
| Principal Investigator: | Tamara Sorić, MSc | Psychiatric Hospital Ugljan |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 14, 2019 | ||||
| First Posted Date ICMJE | July 18, 2019 | ||||
| Last Update Posted Date | July 18, 2019 | ||||
| Actual Study Start Date ICMJE | May 2, 2017 | ||||
| Actual Primary Completion Date | December 20, 2017 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome in Individuals With Schizophrenia | ||||
| Official Title ICMJE | The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome Parameters in Hospitalized Individuals With the Diagnosis of Schizophrenia | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Metabolic Syndrome | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
79 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | December 20, 2017 | ||||
| Actual Primary Completion Date | December 20, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 67 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Croatia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04025073 | ||||
| Other Study ID Numbers ICMJE | TS_01/17 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Tamara Sorić, Psychiatric Hospital Ugljan | ||||
| Study Sponsor ICMJE | Tamara Sorić | ||||
| Collaborators ICMJE | University of Zagreb | ||||
| Investigators ICMJE |
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| PRS Account | Psychiatric Hospital Ugljan | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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