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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Dietary Approaches to Stop Hypertension
Nutrition education program
Sponsored by
Tamara Sorić
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Schizophrenia, Nutrition Therapy

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric Hospital Ugljan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Control Group

Arm Description

The intervention group will be assigned to the DASH diet with moderately reduced caloric intake and will participate in a nutrition education program.

The control group will continue to follow the standard hospital diet and will participate in the same nutrition education program as the intervention group.

Outcomes

Primary Outcome Measures

Change in waist circumference
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
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
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
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
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 Outcome Measures

Change in dietary habits
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.
Change in individual food purchase habits
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.
Dietary intake during the intervention
Dietary intake during the intervention will be assessed using three non-consecutive 24-hour dietary recalls (two weekdays and one weekend day).
Change in participants' mental condition
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.
Change in body weight
Body weight (in kg) will be measured prior to and immediately after the intervention using a digital medical scale witl stadiometer.
Change in body mass index
The measured values of body height and weight will be used for the calculation of body mass index (in kg/m^2).
Change in waist-to-hip ratio
The waist-to-hip ratio will be calculated from the measured values of waist and hip circumferences: waist circumference (cm) / hip circumference (cm).
Change in body fat percentage
Determination of body fat percentage will be performed using OMRON BF500 analyzer.
Change in total cholesterol
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.
Change in low-density lipoprotein cholesterol
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.

Full Information

First Posted
July 14, 2019
Last Updated
July 17, 2019
Sponsor
Tamara Sorić
Collaborators
University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT04025073
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tamara Sorić
Collaborators
University of Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic syndrome, Schizophrenia, Nutrition Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will be assigned to the DASH diet with moderately reduced caloric intake and will participate in a nutrition education program.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
The control group will continue to follow the standard hospital diet and will participate in the same nutrition education program as the intervention group.
Intervention Type
Other
Intervention Name(s)
Dietary Approaches to Stop Hypertension
Other Intervention Name(s)
DASH diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutrition education program
Intervention Description
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 Outcome Measure Information:
Title
Change in waist circumference
Description
Waist circumference measuring (in cm) will be performed prior to and immediately after the intervention using a non-strechable measuring tape.
Time Frame
Baseline and after three months
Title
Change in blood pressure
Description
The assessment of blood pressure (in mmHg) will be performed prior to and immediately after the intervention using an aneroid blood pressure gauge.
Time Frame
Baseline and after three months
Title
Change in high-density lipoprotein cholesterol
Description
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.
Time Frame
Baseline and after three months
Title
Change in serum triglycerides
Description
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.
Time Frame
Baseline and after three months
Title
Change in fasting blood glucose
Description
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.
Time Frame
Baseline and after three months
Secondary Outcome Measure Information:
Title
Change in dietary habits
Description
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.
Time Frame
Baseline and after three months
Title
Change in individual food purchase habits
Description
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.
Time Frame
Baseline and after three months
Title
Dietary intake during the intervention
Description
Dietary intake during the intervention will be assessed using three non-consecutive 24-hour dietary recalls (two weekdays and one weekend day).
Time Frame
3 months
Title
Change in participants' mental condition
Description
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.
Time Frame
Baseline and after three months
Title
Change in body weight
Description
Body weight (in kg) will be measured prior to and immediately after the intervention using a digital medical scale witl stadiometer.
Time Frame
Baseline and after three months
Title
Change in body mass index
Description
The measured values of body height and weight will be used for the calculation of body mass index (in kg/m^2).
Time Frame
Baseline and after three months
Title
Change in waist-to-hip ratio
Description
The waist-to-hip ratio will be calculated from the measured values of waist and hip circumferences: waist circumference (cm) / hip circumference (cm).
Time Frame
Baseline and after three months
Title
Change in body fat percentage
Description
Determination of body fat percentage will be performed using OMRON BF500 analyzer.
Time Frame
Baseline and after three months
Title
Change in total cholesterol
Description
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.
Time Frame
Baseline and after three months
Title
Change in low-density lipoprotein cholesterol
Description
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.
Time Frame
Baseline and after three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Sorić, MSc
Organizational Affiliation
Psychiatric Hospital Ugljan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Hospital Ugljan
City
Ugljan
ZIP/Postal Code
23275
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16157765
Citation
Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available. Erratum In: Circulation. 2005 Oct 25;112(17):e297. Circulation. 2005 Oct 25;112(17):e298.
Results Reference
background
PubMed Identifier
30602666
Citation
Xu H, Li X, Adams H, Kubena K, Guo S. Etiology of Metabolic Syndrome and Dietary Intervention. Int J Mol Sci. 2018 Dec 31;20(1):128. doi: 10.3390/ijms20010128.
Results Reference
background
PubMed Identifier
26407790
Citation
Vancampfort D, Stubbs B, Mitchell AJ, De Hert M, Wampers M, Ward PB, Rosenbaum S, Correll CU. Risk of metabolic syndrome and its components in people with schizophrenia and related psychotic disorders, bipolar disorder and major depressive disorder: a systematic review and meta-analysis. World Psychiatry. 2015 Oct;14(3):339-47. doi: 10.1002/wps.20252.
Results Reference
background
PubMed Identifier
23153955
Citation
Dipasquale S, Pariante CM, Dazzan P, Aguglia E, McGuire P, Mondelli V. The dietary pattern of patients with schizophrenia: a systematic review. J Psychiatr Res. 2013 Feb;47(2):197-207. doi: 10.1016/j.jpsychires.2012.10.005. Epub 2012 Nov 12.
Results Reference
background
PubMed Identifier
22425530
Citation
Ratliff JC, Palmese LB, Reutenauer EL, Liskov E, Grilo CM, Tek C. The effect of dietary and physical activity pattern on metabolic profile in individuals with schizophrenia: a cross-sectional study. Compr Psychiatry. 2012 Oct;53(7):1028-33. doi: 10.1016/j.comppsych.2012.02.003. Epub 2012 Mar 16.
Results Reference
background
PubMed Identifier
17474979
Citation
Amani R. Is dietary pattern of schizophrenia patients different from healthy subjects? BMC Psychiatry. 2007 May 2;7:15. doi: 10.1186/1471-244X-7-15.
Results Reference
background
PubMed Identifier
22030698
Citation
Leao LS, de Moraes MM, de Carvalho GX, Koifman RJ. Nutritional interventions in metabolic syndrome: a systematic review. Arq Bras Cardiol. 2011 Sep;97(3):260-5. doi: 10.1590/s0066-782x2011001200012. English, Portuguese.
Results Reference
background
PubMed Identifier
26354540
Citation
Hill AM, Harris Jackson KA, Roussell MA, West SG, Kris-Etherton PM. Type and amount of dietary protein in the treatment of metabolic syndrome: a randomized controlled trial. Am J Clin Nutr. 2015 Oct;102(4):757-70. doi: 10.3945/ajcn.114.104026. Epub 2015 Sep 9.
Results Reference
background
Links:
URL
https://www.nhlbi.nih.gov/health-topics/dash-eating-plan
Description
DASH diet description, health benefits and main characteristics

Learn more about this trial

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

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