The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome Parameters in Hospitalized Individuals With the Diagnosis of Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Change in waist circumference
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Dietary Approaches to Stop Hypertension (Other)
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.
干预措施: Nutrition education program (Other)
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.
干预措施: Nutrition education program (Other)
结局指标
主要结局
Change in waist circumference
时间窗: 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.
Change in blood pressure
时间窗: 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.
Change in high-density lipoprotein cholesterol
时间窗: 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.
Change in serum triglycerides
时间窗: 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.
Change in fasting blood glucose
时间窗: 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.
次要结局
- Change in individual food purchase habits(Baseline and after three months)
- Dietary intake during the intervention(3 months)
- Change in participants' mental condition(Baseline and after three months)
- Change in body weight(Baseline and after three months)
- Change in body mass index(Baseline and after three months)
- Change in dietary habits(Baseline and after three months)
- Change in waist-to-hip ratio(Baseline and after three months)
- Change in body fat percentage(Baseline and after three months)
- Change in total cholesterol(Baseline and after three months)
- Change in low-density lipoprotein cholesterol(Baseline and after three months)
研究者
Tamara Sorić
Head of Nutrition Department
Psychiatric Hospital Ugljan