Metabolic SyndromeNCT04025073
The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome in Individuals With Schizophrenia
A study testing Dietary Approaches to Stop Hypertension and Nutrition education program in people with Metabolic Syndrome, run by Tamara Sorić at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Dietary Approaches to Stop Hypertension and Nutrition education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCroatia
- Study dates
- 2 May 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome Parameters in Hospitalized Individuals With the Diagnosis of 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.
Read more
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.
- Conditions
- Metabolic Syndrome
- Being tested
- Dietary Approaches to Stop Hypertension, Nutrition education program
- Keywords
- Metabolic syndrome, Schizophrenia, Nutrition Therapy
- Medical subject headings
- Metabolic Syndrome, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Approaches to Stop HypertensionOther
Also called DASH diet
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.
Nutrition education programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will be assigned to the DASH diet with moderately reduced caloric intake and will participate in a nutrition education program. Receives: Other: Dietary Approaches to Stop Hypertension; Other: Nutrition education program |
| Control Group | Experimental | The control group will continue to follow the standard hospital diet and will participate in the same nutrition education program as the intervention group. Receives: Other: Nutrition education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after three months
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.
Measured: Baseline and after three months
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.
Measured: Baseline and after three months
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.
Measured: Baseline and after three months
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.
Measured: Baseline and after three months
Secondary outcomes (10)
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.
Measured: Baseline and after three months
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.
Measured: Baseline and after three months
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).
Measured: 3 months
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.
Measured: Baseline and after three months
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.
Measured: Baseline and after three months
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).
Measured: Baseline and after three months
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).
Measured: Baseline and after three months
Change in body fat percentage
Determination of body fat percentage will be performed using OMRON BF500 analyzer.
Measured: Baseline and after three months
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.
Measured: Baseline and after three months
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.
Measured: Baseline and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start2 May 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamara Sorić
- Collaborators
- University of Zagreb
- Responsible party
- Sponsor-investigator, Tamara Sorić, Psychiatric Hospital Ugljan
- Investigators
- Tamara Sorić, MSc, Principal investigator, Psychiatric Hospital Ugljan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025073
- Sponsor's protocol ID
- TS_01/17
- Status last verified
- Jul 2019
- First submitted
- 14 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16157765Xu 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.
PubMed 30602666Vancampfort 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.
PubMed 26407790Dipasquale 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.
PubMed 23153955Ratliff 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.
PubMed 22425530Amani 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.
PubMed 17474979Leao 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.
PubMed 22030698Hill 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.
PubMed 26354540
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Habits and Nutrition Intervention on Metabolic Syndrome Parameters in Hospitalized Individuals With the Diagnosis of Schizophrenia
- ClinicalTrials.gov ID
- NCT04025073
- Acronym / sponsor ID
- TS_01/17
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, Schizophrenia, Nutrition Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Tamara Sorić
- Collaborators
- University of Zagreb
- Study start
- 2 May 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Dietary Approaches to Stop Hypertension, Other: Nutrition education programThe intervention group will be assigned to the DASH diet with moderately reduced caloric intake and will participate in a nutrition education program. |
| Control Group | Experimental | Other: Nutrition education programThe control group will continue to follow the standard hospital diet and will participate in the same nutrition education program as the intervention group. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Approaches to Stop HypertensionAlso: DASH dietThe 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 | Intervention Group |
| Nutrition education programThe 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. | Other | Control Group, Intervention Group |
Primary outcome
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.
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.
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.
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.
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.
10 secondary outcomes
Change in dietary habits
Time frame: Baseline and after three months
Change in individual food purchase habits
Time frame: Baseline and after three months
Dietary intake during the intervention
Time frame: 3 months
Change in participants' mental condition
Time frame: Baseline and after three months
Change in body weight
Time frame: Baseline and after three months
Change in body mass index
Time frame: Baseline and after three months
Change in waist-to-hip ratio
Time frame: Baseline and after three months
Change in body fat percentage
Time frame: Baseline and after three months
Change in total cholesterol
Time frame: Baseline and after three months
Change in low-density lipoprotein cholesterol
Time frame: Baseline and after three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Background: PubMed 16157765Grundy 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.
- Background: PubMed 30602666Xu 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.
- Background: PubMed 26407790Vancampfort 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.
- Background: PubMed 23153955Dipasquale 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.
- Background: PubMed 22425530Ratliff 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.
- Background: PubMed 17474979Amani 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.
- Background: PubMed 22030698Leao 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.
- Background: PubMed 26354540Hill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Sorić, MSc principal investigator
Psychiatric Hospital Ugljan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Approaches to Stop Hypertension and Nutrition education program in people with Metabolic Syndrome, run by Tamara Sorić at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in waist circumference (time frame: Baseline and after three months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025073, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.