<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/NCT02193659</url>
  </required_header>
  <id_info>
    <org_study_id>Elena García-García 3</org_study_id>
    <secondary_id>Enrique Roche Collado</secondary_id>
    <nct_id>NCT02193659</nct_id>
  </id_info>
  <brief_title>Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile</brief_title>
  <acronym>cereals</acronym>
  <official_title>Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Miguel Hernandez de Elche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Miguel Hernandez de Elche</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who&#xD;
      had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance.&#xD;
      The main objective is to assess the effect of breakfast cereals intake with omega-3 on women&#xD;
      lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the&#xD;
      small dyslipidemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators performed an intervention including 133 women (age 25-70 years).&#xD;
      Participants were randomly and single-blind distributed into three groups: Group 1 (n=38)&#xD;
      consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers&#xD;
      consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit&#xD;
      levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol,&#xD;
      triglycerides and glucose were determined at the beginning and end of a 30-day test.&#xD;
&#xD;
      Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint&#xD;
      Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data&#xD;
      are reported as mean ± standard error of the mean (sem). Intra-group statistical comparisons&#xD;
      were performed using the following hypothesis tests, both parametric and non-parametric:&#xD;
      t-test, sign test and signed rank test for paired samples. Inter-group statistical&#xD;
      comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis&#xD;
      hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and&#xD;
      Tukey's honestly significant difference (HSD) were used in order to determine which means&#xD;
      were significantly different from the others. In addition, Generalized Multiple Regression&#xD;
      was used to statistically analyze the relationships between the variations in the lipid&#xD;
      profile and the different factors included in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>Circulating parameters of cholesterol total</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>In this table the investigators present the weight of the three intervented groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>Circulating parameters of cholesterol HDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>Circulating parameters of cholesterol LDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>Circulating parameters of triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>Circulating parameters of glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>In this table the investigators present the BMI of the three intervented groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>In this table the investigators present the hip / waist measure of the three intervented groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>In this table the investigators present the systolic pressure of the three intervented groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.</measure>
    <time_frame>30 days</time_frame>
    <description>In this table the investigators present the diastolic pressure of the three intervented groups</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Cereals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet. The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cereals</intervention_name>
    <description>The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37). For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.</description>
    <arm_group_label>Cereals</arm_group_label>
    <other_name>Papilla multicereales con Omega-3 0628413</other_name>
    <other_name>Papilla multicereales 0528413</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  voluntarily participation&#xD;
&#xD;
          -  ages between 25-70 years&#xD;
&#xD;
          -  undergoing dyslipidemia&#xD;
&#xD;
          -  with no pharmacological treatment&#xD;
&#xD;
          -  cholesterol (250-300 mg/dL)&#xD;
&#xD;
          -  triglycerides (160-175 mg/dL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects undergoing any pharmacological treatment that may influence lipid metabolism&#xD;
&#xD;
          -  lipid levels outside the range of those specified in the inclusion criteria&#xD;
&#xD;
          -  subjects that were deemed to be unlikely to complete the treatment or to cooperate&#xD;
             fully at the investigator´s discretion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena García-García, PDI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Miguel Hernandez de Elche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pharmacy Iborra Campos</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>February 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>August 24, 2015</last_update_submitted>
  <last_update_submitted_qc>August 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Miguel Hernandez de Elche</investigator_affiliation>
    <investigator_full_name>Elena García García</investigator_full_name>
    <investigator_title>PhD, PID</investigator_title>
  </responsible_party>
  <keyword>breakfast cereal</keyword>
  <keyword>omega-3</keyword>
  <keyword>cholesterol</keyword>
  <keyword>lipidic profile</keyword>
  <keyword>consumption</keyword>
  <keyword>acceptability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02193659
org study id: Elena García-García 3
secondary id: Enrique Roche Collado
nct id: NCT02193659
lead sponsor: 
collaborator: 
has dmc: Yes
The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who
      had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance.
      The main objective is to assess the effect of breakfast cereals intake with omega-3 on women
      lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the
      small dyslipidemia.
The investigators performed an intervention including 133 women (age 25-70 years).
      Participants were randomly and single-blind distributed into three groups: Group 1 (n=38)
      consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers
      consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit
      levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol,
      triglycerides and glucose were determined at the beginning and end of a 30-day test.

      Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint
      Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data
      are reported as mean ± standard error of the mean (sem). Intra-group statistical comparisons
      were performed using the following hypothesis tests, both parametric and non-parametric:
      t-test, sign test and signed rank test for paired samples. Inter-group statistical
      comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis
      hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and
      Tukey's honestly significant difference (HSD) were used in order to determine which means
      were significantly different from the others. In addition, Generalized Multiple Regression
      was used to statistically analyze the relationships between the variations in the lipid
      profile and the different factors included in the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: Circulating parameters of cholesterol total
measure: Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: In this table the investigators present the weight of the three intervented groups
measure: Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: Circulating parameters of cholesterol HDL
measure: Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: Circulating parameters of cholesterol LDL
measure: Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: Circulating parameters of triglycerides
measure: Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: Circulating parameters of glucose
measure: BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: In this table the investigators present the BMI of the three intervented groups
measure: Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: In this table the investigators present the hip / waist measure of the three intervented groups
measure: Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: In this table the investigators present the systolic pressure of the three intervented groups
measure: Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
time frame: 30 days
description: In this table the investigators present the diastolic pressure of the three intervented groups
arm group label: Cereals
arm group type: Experimental
description: For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet. The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day).
intervention type: Dietary Supplement
intervention name: Cereals
description: The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37). For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.
arm group label: Cereals
other name: Papilla multicereales con Omega-3 0628413
other name: Papilla multicereales 0528413
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
last name: Elena García-García, PDI
role: Principal Investigator
affiliation: Universidad Miguel Hernandez de Elche
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Miguel Hernandez de Elche
investigator full name: Elena García García
investigator title: PhD, PID
mesh term: Overweight