xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05980663</url>
    </required_header>
    <id_info>
      <org_study_id>KK.01.1.1.07.0075_2</org_study_id>
      <nct_id>NCT05980663</nct_id>
    </id_info>
    <brief_title>Evaluation of the Effectiveness of Standard and Innovative Products That Represent a Substitute Meal for Weight Management in a Reduction Diet in Obese Participants With Asthma</brief_title>
    <official_title>Randomized Stratified Controlled Clinical Study for Evaluating the Effectiveness of a Diet Program Designed for Reducing Body Weight Using Standard and Innovative Products in Obese Participants With Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital Srebrnjak</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Belupo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Podravka d.d.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Hospital Srebrnjak</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Randomized stratified controlled clinical study for evaluate the effectiveness of a diet&#xD;
        program designed for reduce body weight through standard and innovative products that are a&#xD;
        substitute meal for weight management in a reduction diet in obese participants with asthma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the last few decades, there has been an increase in the number of obese people to the&#xD;
        level of a global epidemic as a result of inadequate diet, sedentary lifestyle, but also&#xD;
        genetic predispositions. The World Health Organization (WHO) declared obesity to be the&#xD;
        biggest, global, chronic health problem in adults, that is increasingly becoming a more&#xD;
        serious problem than malnutrition.On the other hand, obesity is a risk factor for the&#xD;
        development of contemporary non-infectious diseases today that account for more than 80% of&#xD;
        mortality in developed countries, such as vascular disease, diabetes and respiratory diseases&#xD;
        such as asthma.&#xD;
  &#xD;
        This trend is also recorded in Croatia, both in adult population and in children if the data&#xD;
        from 2003 and 2015 are being compared, while according to data from 2019, almost two thirds&#xD;
        of the adult population in Croatia were overweight or obese (42% overweight, 23% obese).&#xD;
  &#xD;
        Of particular concern are the data from the European Obesity Monitoring Initiative from&#xD;
        2018/2019. according to which in Croatia 35% of children aged 8.0 to 8.9 were overweight or&#xD;
        obese. At the national level, the problem of obesity is greater in boys than in girls, and it&#xD;
        is 17.8% compared to 11.9% of girls. Croatia is in a high fifth place together with other&#xD;
        countries of the Mediterranean region of Europe due to the shift from the Mediterranean to&#xD;
        the Western lifestyle.&#xD;
  &#xD;
        In cooperation with Podravka, Belupo has developed a standard and innovative product line.&#xD;
        Products are replacing one or more one or more daily meals, and thay must comply with&#xD;
        Regulation 2016/1413 requirements related to energy value, content and composition of fats&#xD;
        and proteins, the amount of vitamins and minerals in this type of products.&#xD;
  &#xD;
        The standard product line contains common ingredients and this type of product already exists&#xD;
        on world markets, while the innovative product line differs from the standard one by&#xD;
        implementing raw materials that are considered better sources of potentially bioactive&#xD;
        components.&#xD;
  &#xD;
        The study for a group of adult participants was designed in such a way that the participants&#xD;
        in the initial stage follow a low-calorie diet of about 1000 - 1100 kcal, whereby 5 daily&#xD;
        meals are replaced with meal replacements in the reduction diet (active group and active&#xD;
        control) (intensive phase). In subsequent stages, subjects gradually increase their energy&#xD;
        intake and gradually substitute meal replacement product (MRP) with regular nutritionally&#xD;
        profiled meals (active phase and maintenance phase). The final (stable) phase represents the&#xD;
        stage in which, in addition to one meal replacement per day, the usual meals designed by the&#xD;
        nutritionists of Belupo and the Culinary Center of Podravka are consumed, where education and&#xD;
        nutrition counseling is also carried out.&#xD;
  &#xD;
        The study for the child population of respondents is designed in such a way that the&#xD;
        respondents in the initial phase implement a low-calorie diet of about 1300-1500 kcal,&#xD;
        whereby 3 daily meals are replaced with meal replacements in the reduction diet in addition&#xD;
        to 2 nutritionally balanced regular meals that include a minimum of 5 daily servings of&#xD;
        fruits and vegetables (active group and active control) (intensive phase).&#xD;
  &#xD;
        In subsequent phases, subjects gradually increase their energy intake and gradually replace&#xD;
        MRP with regular nutritionally profiled meals (active phase and stable phase). The final&#xD;
        phase represents the phase in which subjects consume the usual meals designed by the&#xD;
        nutritionists of Children's hospital Srebrnjak, where education and nutrition counseling is&#xD;
        also carried out.&#xD;
  &#xD;
        The usual meals of the later stages of the study, apart from being low in energy and highly&#xD;
        nutritionally dense are composed in such a way that they are either ready for consumption as&#xD;
        a complete meal (e.g. ready- to eat tuna salad) or can be quickly prepared. In this way, the&#xD;
        test respondents are directed to an adequate diet, which, by adopting proper food and&#xD;
        lifestyle habits, will ultimately enable them to maintain the achieved reduced body weight in&#xD;
        the long term.&#xD;
  &#xD;
        Study entry stage (0-2 weeks): subjects are recruited respecting the inclusion and exclusion&#xD;
        criteria. Recruitment is carried out by a doctor. During this stage, subjects replace&#xD;
        standard meals with meal replacement products and reduce energy intake to a final defined&#xD;
        intake depending on the group of subjects.&#xD;
  &#xD;
        200 participants in a ratio of 2:1:1 (adults and children)&#xD;
  &#xD;
          -  active group - 80&#xD;
  &#xD;
          -  active control (positive control group) - 80&#xD;
  &#xD;
          -  control group (negative control group) - 40&#xD;
  &#xD;
        Adult participants program:&#xD;
  &#xD;
        The daily energy intake is defined at around 1000-1100 kcal per day, and counseling on&#xD;
        nutrition and physical activity is carried out.&#xD;
  &#xD;
          1. Intensive phase(2-14 weeks) about 1000 - 1100 kcal/day 5 MRP (200-220 kcal per product)&#xD;
             + 1 salad (20 kcal per portion) + water/unsweetened tea.&#xD;
  &#xD;
          2. Active phase(14-21 weeks) 1100-1200 kcal/day 3 MRP (200-220 kcal per meal) + 2 regular&#xD;
             meals (200-280 kcal) + water/unsweetened tea.&#xD;
  &#xD;
          3. Maintenance phase (21-28 weeks): 1200-1500 kcal/day 2 MRP (200-220 kcal per meal) + 3&#xD;
             regular meals (260-350 kcal) + water/unsweetened tea&#xD;
  &#xD;
          4. Stable phase (28-40 weeks): 1500-2000 kcal 1 MRP (200-220 kcal per meal) + 4 regular&#xD;
             meals (approx. 320-450 kcal) + water/unsweetened tea Usual meals can also contain snacks&#xD;
             with lower energy values, but it is important to consume approx. 1300-1800 kcal per day&#xD;
             with usual foods.&#xD;
  &#xD;
        Children participants program:&#xD;
  &#xD;
        The daily energy intake is defined at around 1300-1500 kcal per day, and counseling on&#xD;
        nutrition and physical activity is carried out.&#xD;
  &#xD;
          1. Intensive phase children (weeks 2-14) around 1300-1500 kcal/day 3 MPR (200-220 kcal per&#xD;
             product + 2 regular meals (320-400 kcal) + 1 or more salad (20 kcal per product)+&#xD;
             water/unsweetened tea.&#xD;
  &#xD;
          2. Active phase children (14-21 weeks) around 140-1600kcal/day 2 MPR (200-220 kcal per&#xD;
             product) + 3 regular meals (320-400 kcal) + water/unsweetened tea.&#xD;
  &#xD;
          3. Maintenance phase (21-28 weeks): 1600-1900 kcal/day 1 MRP (200-220 kcal per meal) + 4&#xD;
             regular meals (350-420 kcal) + water/unsweetened tea&#xD;
  &#xD;
          4. Stable phase children (week 28-40) 1750-2250 kcal/day. 5 regular meals (350-450 kcal) +&#xD;
             water/unsweetened tea.&#xD;
  &#xD;
        Snacks are included in regular meals, where the total value of meals and snacks does not&#xD;
        exceed the total set value of regular meals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 17, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized stratified controlled clinical study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>BM/FM</measure>
      <time_frame>every 4 weeks, through study completition (up to 9 months)</time_frame>
      <description>To determine the effectiveness of a weight change diet program based on an innovative and standard product line through actual reduction of the body mass (BM) / fat mass (FM) of the participants in relation to their pre - trial body mass(BM)/fat mass (FM).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anthropometric measurements</measure>
      <time_frame>every 2 months, through study completition (up to 9 months)</time_frame>
      <description>Change in anthropometric measurements- waist and hip circumference and waist/hip ratio and waist/height ratio&#xD;
  Measurements of participants' waist, hip and height in meters will be taken. This multiple measurements will be aggregated and presented in ratio waist [meter] / hip [meter] and ratio waist [meter] / height [meter]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lipid profile (triglycerides, total cholesterol, HDL, LDL)</measure>
      <time_frame>at 1st week of the study and after 3, 6 and 9 months, through study completition (up to 9 months)</time_frame>
      <description>Change of the cholesterol test/lipid panel/lipid profile (change in HDL/LDL ratio) compared to initial values</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaire on quality of life</measure>
      <time_frame>at the beginning of the study (1st week) and at the end (40th week)</time_frame>
      <description>The questionnaire consists of descriptive system and visual analogue scale.&#xD;
  The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.&#xD;
  The visual analogue scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.&#xD;
  The questionnaire is in Croatian language, with a valid and accurate translation of the corresponding original document.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of asthma control</measure>
      <time_frame>every 3 months, through study completition (up to 9 months)</time_frame>
      <description>ACT Questionnaire will be used to tell us if the asthma treatment plan is optimal and if asthma is being properly controlled. Maximal score is 25, where higher scores reflect greater asthma control while if the score is 19 or less that may be a sign that asthma is not controlled as well as it could be.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the number of asthma exacerbations and severity</measure>
      <time_frame>every 3 months,through study completition (up to 9 months)</time_frame>
      <description>The the number of exacerbations will be recorded along with the therapy used (use of salbutamol, oral or parenteral corticosteroids etc.)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Obesity</condition>
    <condition>Asthma</condition>
    <condition>Overweight</condition>
    <arm_group>
      <arm_group_label>Active group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants use the innovative line of products intended for body weight reduction, that represent a meal replacement for weight management.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants use the standard line of products intended for weight reduction that represent a meal replacement for weight management with already proven clinical effectiveness (positive control).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants receive personalized advice on proper nutrition for a reduction diet in which they use common food.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Meal replacement product- STANDARD PRODUCT</intervention_name>
      <description>standard product line contains common ingredients and this type of product already exists on world markets</description>
      <arm_group_label>Active control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Meal replacement product- INNOVATIVE PRODUCT</intervention_name>
      <description>innovative product line contains raw materials that are considered better sources of potentially bioactive components</description>
      <arm_group_label>Active group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults aged 18-60, children aged 12-18&#xD;
  &#xD;
            -  both sexes&#xD;
  &#xD;
            -  BMI &gt;27 kg/m2 (adults); &gt; 90th centile for BMI (children)&#xD;
  &#xD;
            -  clinical diagnosis of asthma&#xD;
  &#xD;
            -  signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  significant comorbidities: uncontrolled diabetes mellitus requiring insulin therapy&#xD;
               and other endocrine disorders, cardiovascular disorders and other chronic diseases&#xD;
               (including malignancies), chronic inflammatory diseases of the gastrointestinal tract,&#xD;
               mental disorder&#xD;
  &#xD;
            -  people who are currently on or have recently gone through a weight loss program (in&#xD;
               the past 3 months)&#xD;
  &#xD;
            -  people who in the past 6 months had an unwanted and uncontrolled loss of body weight&#xD;
               &gt;5%&#xD;
  &#xD;
            -  people who underwent bariatric surgery in the past 6 months.&#xD;
  &#xD;
            -  people using drugs that increase or decrease appetite&#xD;
  &#xD;
            -  permanent therapy with steroid drugs, antidepressants, cytostatics, hormone therapy,&#xD;
               beta-blockers, etc.&#xD;
  &#xD;
            -  people with eating disorders (bulimia)&#xD;
  &#xD;
            -  alcohol and drug addicts&#xD;
  &#xD;
            -  pregnancy, breastfeeding&#xD;
  &#xD;
            -  unstable thyroid disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mirjana Turkalj, Prof., MD</last_name>
      <phone>+38516391164</phone>
      <email>mturkalj@bolnica-srebrnjak.hr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Children's Hospital Srebrnjak</name>
        <address>
          <city>Zagreb</city>
          <zip>10000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mirjana Turkalj, MD, PhD</last_name>
        <phone>+38516391164</phone>
        <email>mturkalj@bolnica-srebrnjak.hr</email>
      </contact>
      <investigator>
        <last_name>Mirjana Turkalj, Prof,MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Croatia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Hospital Srebrnjak</investigator_affiliation>
      <investigator_full_name>Mirjana Turkalj, MD</investigator_full_name>
      <investigator_title>Professor, MD, PhD</investigator_title>
    </responsible_party>
    <keyword>obesity</keyword>
    <keyword>asthma</keyword>
    <keyword>overweight</keyword>
    <keyword>nutrition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05980663
  org study id: KK.01.1.1.07.0075_2
  nct id: NCT05980663
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Randomized stratified controlled clinical study for evaluate the effectiveness of a diet
        program designed for reduce body weight through standard and innovative products that are a
        substitute meal for weight management in a reduction diet in obese participants with asthma.
  In the last few decades, there has been an increase in the number of obese people to the
        level of a global epidemic as a result of inadequate diet, sedentary lifestyle, but also
        genetic predispositions. The World Health Organization (WHO) declared obesity to be the
        biggest, global, chronic health problem in adults, that is increasingly becoming a more
        serious problem than malnutrition.On the other hand, obesity is a risk factor for the
        development of contemporary non-infectious diseases today that account for more than 80% of
        mortality in developed countries, such as vascular disease, diabetes and respiratory diseases
        such as asthma.
  
        This trend is also recorded in Croatia, both in adult population and in children if the data
        from 2003 and 2015 are being compared, while according to data from 2019, almost two thirds
        of the adult population in Croatia were overweight or obese (42% overweight, 23% obese).
  
        Of particular concern are the data from the European Obesity Monitoring Initiative from
        2018/2019. according to which in Croatia 35% of children aged 8.0 to 8.9 were overweight or
        obese. At the national level, the problem of obesity is greater in boys than in girls, and it
        is 17.8% compared to 11.9% of girls. Croatia is in a high fifth place together with other
        countries of the Mediterranean region of Europe due to the shift from the Mediterranean to
        the Western lifestyle.
  
        In cooperation with Podravka, Belupo has developed a standard and innovative product line.
        Products are replacing one or more one or more daily meals, and thay must comply with
        Regulation 2016/1413 requirements related to energy value, content and composition of fats
        and proteins, the amount of vitamins and minerals in this type of products.
  
        The standard product line contains common ingredients and this type of product already exists
        on world markets, while the innovative product line differs from the standard one by
        implementing raw materials that are considered better sources of potentially bioactive
        components.
  
        The study for a group of adult participants was designed in such a way that the participants
        in the initial stage follow a low-calorie diet of about 1000 - 1100 kcal, whereby 5 daily
        meals are replaced with meal replacements in the reduction diet (active group and active
        control) (intensive phase). In subsequent stages, subjects gradually increase their energy
        intake and gradually substitute meal replacement product (MRP) with regular nutritionally
        profiled meals (active phase and maintenance phase). The final (stable) phase represents the
        stage in which, in addition to one meal replacement per day, the usual meals designed by the
        nutritionists of Belupo and the Culinary Center of Podravka are consumed, where education and
        nutrition counseling is also carried out.
  
        The study for the child population of respondents is designed in such a way that the
        respondents in the initial phase implement a low-calorie diet of about 1300-1500 kcal,
        whereby 3 daily meals are replaced with meal replacements in the reduction diet in addition
        to 2 nutritionally balanced regular meals that include a minimum of 5 daily servings of
        fruits and vegetables (active group and active control) (intensive phase).
  
        In subsequent phases, subjects gradually increase their energy intake and gradually replace
        MRP with regular nutritionally profiled meals (active phase and stable phase). The final
        phase represents the phase in which subjects consume the usual meals designed by the
        nutritionists of Children's hospital Srebrnjak, where education and nutrition counseling is
        also carried out.
  
        The usual meals of the later stages of the study, apart from being low in energy and highly
        nutritionally dense are composed in such a way that they are either ready for consumption as
        a complete meal (e.g. ready- to eat tuna salad) or can be quickly prepared. In this way, the
        test respondents are directed to an adequate diet, which, by adopting proper food and
        lifestyle habits, will ultimately enable them to maintain the achieved reduced body weight in
        the long term.
  
        Study entry stage (0-2 weeks): subjects are recruited respecting the inclusion and exclusion
        criteria. Recruitment is carried out by a doctor. During this stage, subjects replace
        standard meals with meal replacement products and reduce energy intake to a final defined
        intake depending on the group of subjects.
  
        200 participants in a ratio of 2:1:1 (adults and children)
  
          -  active group - 80
  
          -  active control (positive control group) - 80
  
          -  control group (negative control group) - 40
  
        Adult participants program:
  
        The daily energy intake is defined at around 1000-1100 kcal per day, and counseling on
        nutrition and physical activity is carried out.
  
          1. Intensive phase(2-14 weeks) about 1000 - 1100 kcal/day 5 MRP (200-220 kcal per product)
             + 1 salad (20 kcal per portion) + water/unsweetened tea.
  
          2. Active phase(14-21 weeks) 1100-1200 kcal/day 3 MRP (200-220 kcal per meal) + 2 regular
             meals (200-280 kcal) + water/unsweetened tea.
  
          3. Maintenance phase (21-28 weeks): 1200-1500 kcal/day 2 MRP (200-220 kcal per meal) + 3
             regular meals (260-350 kcal) + water/unsweetened tea
  
          4. Stable phase (28-40 weeks): 1500-2000 kcal 1 MRP (200-220 kcal per meal) + 4 regular
             meals (approx. 320-450 kcal) + water/unsweetened tea Usual meals can also contain snacks
             with lower energy values, but it is important to consume approx. 1300-1800 kcal per day
             with usual foods.
  
        Children participants program:
  
        The daily energy intake is defined at around 1300-1500 kcal per day, and counseling on
        nutrition and physical activity is carried out.
  
          1. Intensive phase children (weeks 2-14) around 1300-1500 kcal/day 3 MPR (200-220 kcal per
             product + 2 regular meals (320-400 kcal) + 1 or more salad (20 kcal per product)+
             water/unsweetened tea.
  
          2. Active phase children (14-21 weeks) around 140-1600kcal/day 2 MPR (200-220 kcal per
             product) + 3 regular meals (320-400 kcal) + water/unsweetened tea.
  
          3. Maintenance phase (21-28 weeks): 1600-1900 kcal/day 1 MRP (200-220 kcal per meal) + 4
             regular meals (350-420 kcal) + water/unsweetened tea
  
          4. Stable phase children (week 28-40) 1750-2250 kcal/day. 5 regular meals (350-450 kcal) +
             water/unsweetened tea.
  
        Snacks are included in regular meals, where the total value of meals and snacks does not
        exceed the total set value of regular meals.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized stratified controlled clinical study
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: BM/FM
  time frame: every 4 weeks, through study completition (up to 9 months)
  description: To determine the effectiveness of a weight change diet program based on an innovative and standard product line through actual reduction of the body mass (BM) / fat mass (FM) of the participants in relation to their pre - trial body mass(BM)/fat mass (FM).
  measure: Anthropometric measurements
  time frame: every 2 months, through study completition (up to 9 months)
  description: Change in anthropometric measurements- waist and hip circumference and waist/hip ratio and waist/height ratio
  Measurements of participants' waist, hip and height in meters will be taken. This multiple measurements will be aggregated and presented in ratio waist [meter] / hip [meter] and ratio waist [meter] / height [meter]
  measure: Lipid profile (triglycerides, total cholesterol, HDL, LDL)
  time frame: at 1st week of the study and after 3, 6 and 9 months, through study completition (up to 9 months)
  description: Change of the cholesterol test/lipid panel/lipid profile (change in HDL/LDL ratio) compared to initial values
  measure: Questionnaire on quality of life
  time frame: at the beginning of the study (1st week) and at the end (40th week)
  description: The questionnaire consists of descriptive system and visual analogue scale.
  The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
  The visual analogue scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
  The questionnaire is in Croatian language, with a valid and accurate translation of the corresponding original document.
  measure: Change of asthma control
  time frame: every 3 months, through study completition (up to 9 months)
  description: ACT Questionnaire will be used to tell us if the asthma treatment plan is optimal and if asthma is being properly controlled. Maximal score is 25, where higher scores reflect greater asthma control while if the score is 19 or less that may be a sign that asthma is not controlled as well as it could be.
  measure: Change in the number of asthma exacerbations and severity
  time frame: every 3 months,through study completition (up to 9 months)
  description: The the number of exacerbations will be recorded along with the therapy used (use of salbutamol, oral or parenteral corticosteroids etc.)
  arm group label: Active group
  arm group type: Experimental
  description: Participants use the innovative line of products intended for body weight reduction, that represent a meal replacement for weight management.
  arm group label: Active control
  arm group type: Active Comparator
  description: Participants use the standard line of products intended for weight reduction that represent a meal replacement for weight management with already proven clinical effectiveness (positive control).
  arm group label: Control group
  arm group type: No Intervention
  description: Participants receive personalized advice on proper nutrition for a reduction diet in which they use common food.
  intervention type: Dietary Supplement
  intervention name: Meal replacement product- STANDARD PRODUCT
  description: standard product line contains common ingredients and this type of product already exists on world markets
  arm group label: Active control
  intervention type: Dietary Supplement
  intervention name: Meal replacement product- INNOVATIVE PRODUCT
  description: innovative product line contains raw materials that are considered better sources of potentially bioactive components
  arm group label: Active group
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Mirjana Turkalj, Prof., MD
  phone: +38516391164
  email: mturkalj@bolnica-srebrnjak.hr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Croatia
  responsible party type: Principal Investigator
  investigator affiliation: Children's Hospital Srebrnjak
  investigator full name: Mirjana Turkalj, MD
  investigator title: Professor, MD, PhD
  mesh term: Asthma
  mesh term: Overweight