<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/NCT03014531</url>
  </required_header>
  <id_info>
    <org_study_id>14-KIMH-01-ICAN</org_study_id>
    <nct_id>NCT03014531</nct_id>
  </id_info>
  <brief_title>Effects of Daily Almond Intake as a Preload Before Meals Versus as a Snack Among Korean Adults</brief_title>
  <official_title>Daily Almond Intake as a Preload Before Meals Versus as a Snack Between Meals Has Different Effects on Body Fat Percentages and the Lipid Profile in a Randomized Controlled Trial of Young Adults in South Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ICAN Nutrition Education and Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Almond Board of California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ICAN Nutrition Education and Research</source>
  <brief_summary>
    <textblock>
      The study was conducted to investigate the effects of daily almond intake based on the timing&#xD;
      of almond consumption (i.e., almond consumption as a preload or between-meal snack) on body&#xD;
      composition, lipid profile, and oxidative and inflammation indicators among young Korean&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study was conducted to investigate the effects of daily almond intake on body&#xD;
      composition, lipid profile, and oxidative and inflammation indicators among young Korean&#xD;
      adults based on the timing of almond consumption. Participants were randomly assigned to one&#xD;
      of three groups: (1) a pre-meal group (PM; n = 58) in which participants were instructed to&#xD;
      consume 56 g of almonds per day as a preload when having regular meals; (2) a snack group&#xD;
      (SN; n =55) in which participants were instructed to consume 56 g of almonds between meals as&#xD;
      snacks; and (3) a control group (CL; n = 56) in which participants were provided&#xD;
      high-carbohydrate iso-caloric control food. The three-day diet records, including two&#xD;
      consecutive weekdays and one weekend day, were done once before the trial and twice during&#xD;
      the trial. Body composition was assessed through multi-frequency whole-body bioimpedance&#xD;
      measurement using InBody 620 (Biospace Co., Ltd, Seoul, Korea).After a 12-hour fast, blood&#xD;
      samples were taken at the baseline time point (week 0) and at weeks 8 and 16 by standard&#xD;
      venipuncture. The serum total cholesterol and triglycerides levels were measured by the&#xD;
      enzymatic-colorimetric method using a Cobas 8000 c702 chemistry analyzer (Roche Diagnostics;&#xD;
      Mannheim, Germany). HDL cholesterol and LDL cholesterol levels were determined via&#xD;
      homogeneous enzymatic colorimetry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of body fat percentages from baseline</measure>
    <time_frame>week 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of blood lipid profiles from baseline</measure>
    <time_frame>week 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of body fat percentages from baseline</measure>
    <time_frame>week 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of blood lipid profiles from baseline</measure>
    <time_frame>week 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of body fat percentages from baseline</measure>
    <time_frame>week 20</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of blood lipid profiles from baseline</measure>
    <time_frame>week 20</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of blood IL-6 levels</measure>
    <time_frame>week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of blood IL-6 levels</measure>
    <time_frame>week 16</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">227</enrollment>
  <condition>Adult Young and Healthy</condition>
  <arm_group>
    <arm_group_label>almond</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, participants were provided with 56 g of almonds per day either as preload before meals or snack between meals. A snack was defined as an eating event that occurred between participants' regular meals, specifically two hours before and after meals. All the participants in almond group were provided daily portions of packaged almonds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high-carbohydrate control food item</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this group, participants were provided with high-carbohydrate control food item that had a similar number of calories as 56 g of almonds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>almond</intervention_name>
    <arm_group_label>almond</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high-carbohydrate control food</intervention_name>
    <arm_group_label>high-carbohydrate control food item</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-smokers&#xD;
&#xD;
          -  age 20-39 yr&#xD;
&#xD;
          -  Male and Female non-smokers&#xD;
&#xD;
          -  BMI 17-30 kg/m2&#xD;
&#xD;
          -  under Korean habitual diet&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  any diseases&#xD;
&#xD;
          -  any weight change 6 mo before the study&#xD;
&#xD;
          -  &gt;2 times/wk nut consumption&#xD;
&#xD;
          -  frequent alcohol consumption&#xD;
&#xD;
          -  any use of nutrient supplements&#xD;
&#xD;
          -  erratic exercise habits&#xD;
&#xD;
          -  women who were with irregular menses, taking birth control pills, pregnant or&#xD;
             lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ICAN Nutrition Education and Research</name>
      <address>
        <city>Seoul</city>
        <zip>07327</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03014531
org study id: 14-KIMH-01-ICAN
nct id: NCT03014531
lead sponsor: 
collaborator: 
The study was conducted to investigate the effects of daily almond intake based on the timing
      of almond consumption (i.e., almond consumption as a preload or between-meal snack) on body
      composition, lipid profile, and oxidative and inflammation indicators among young Korean
      adults.
The current study was conducted to investigate the effects of daily almond intake on body
      composition, lipid profile, and oxidative and inflammation indicators among young Korean
      adults based on the timing of almond consumption. Participants were randomly assigned to one
      of three groups: (1) a pre-meal group (PM; n = 58) in which participants were instructed to
      consume 56 g of almonds per day as a preload when having regular meals; (2) a snack group
      (SN; n =55) in which participants were instructed to consume 56 g of almonds between meals as
      snacks; and (3) a control group (CL; n = 56) in which participants were provided
      high-carbohydrate iso-caloric control food. The three-day diet records, including two
      consecutive weekdays and one weekend day, were done once before the trial and twice during
      the trial. Body composition was assessed through multi-frequency whole-body bioimpedance
      measurement using InBody 620 (Biospace Co., Ltd, Seoul, Korea).After a 12-hour fast, blood
      samples were taken at the baseline time point (week 0) and at weeks 8 and 16 by standard
      venipuncture. The serum total cholesterol and triglycerides levels were measured by the
      enzymatic-colorimetric method using a Cobas 8000 c702 chemistry analyzer (Roche Diagnostics;
      Mannheim, Germany). HDL cholesterol and LDL cholesterol levels were determined via
      homogeneous enzymatic colorimetry.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes of body fat percentages from baseline
time frame: week 8
measure: Changes of blood lipid profiles from baseline
time frame: week 8
measure: Changes of body fat percentages from baseline
time frame: week 16
measure: Changes of blood lipid profiles from baseline
time frame: week 16
measure: Changes of body fat percentages from baseline
time frame: week 20
measure: Changes of blood lipid profiles from baseline
time frame: week 20
measure: Changes of blood IL-6 levels
time frame: week 8
measure: Changes of blood IL-6 levels
time frame: week 16
arm group label: almond
arm group type: Experimental
description: In this group, participants were provided with 56 g of almonds per day either as preload before meals or snack between meals. A snack was defined as an eating event that occurred between participants' regular meals, specifically two hours before and after meals. All the participants in almond group were provided daily portions of packaged almonds.
arm group label: high-carbohydrate control food item
arm group type: Other
description: In this group, participants were provided with high-carbohydrate control food item that had a similar number of calories as 56 g of almonds.
intervention type: Other
intervention name: almond
arm group label: almond
intervention type: Other
intervention name: high-carbohydrate control food
arm group label: high-carbohydrate control food item
criteria: 
gender: All
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor