<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/NCT02217124</url>
  </required_header>
  <id_info>
    <org_study_id>S17213</org_study_id>
    <nct_id>NCT02217124</nct_id>
  </id_info>
  <brief_title>Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite</brief_title>
  <official_title>Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Diego State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the proposed research is to determine the influence of 8 weeks of&#xD;
      twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat&#xD;
      120kcal muffin on components of obesity (waist circumference [waist measurement], serum&#xD;
      glucose [blood sugar], triglycerides [fats in the blood] and HDL-cholesterol, and blood&#xD;
      pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight&#xD;
      and obese individuals. A total of 48 children aged 10-16 years will be randomly assigned to&#xD;
      groups and provided with twice daily 120 kcal servings of either dried apples or muffins for&#xD;
      8 weeks of feeding. Prior to initiating the feeding trial and again after 8 weeks, blood&#xD;
      samples will be collected and analyzed. During each visit to the lab, subjects will be&#xD;
      weighed in minimal clothing, tested for body composition using dual energy X-ray&#xD;
      absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography (Bod&#xD;
      Pod) and blood pressure, and measured for waist circumference. One 24-hour recall will be&#xD;
      performed prior to initiation of the study; one recall will be performed throughout the&#xD;
      feeding period, and one at the end of the 8 weeks. Dietary intake of energy, macronutrients,&#xD;
      vitamins and minerals will be assessed to determine diet quality. All food records will be&#xD;
      analyzed using the Nutritionist Pro (First DataBank) software. The potential benefits of the&#xD;
      study include determining the effects of consistent snacking and particular snack foods on&#xD;
      metabolism and weight management. There are no major risks to subjects in this study. There&#xD;
      are minimal risks when performing venipuncture (blood draws) including bruising, perforation&#xD;
      of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of&#xD;
      needles, and infection. This study will hopefully allow more understanding and insight into&#xD;
      the diet of children and the effect of it on body makeup and blood sugar. It is hypothesized&#xD;
      that the twice a day apple snack group will have decreased waist circumference, body&#xD;
      adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at&#xD;
      the end of 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">February 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Body Composition at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>Height, Weight, waist circumference, Body Mass Index are all used to asses body composition. Bod pod, BIA, and Dexa are also used to obtain the body composition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of triglycerides at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline blood glucose at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>Used to examine glucose regulation as effected by the apple group intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Apple group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>twenty four participants will be randomly selected for the apple group, in which they will receive 37.5 grams equal to 120kcal of dried apples twice a day for eight weeks. This snack of apples will be eaten once between breakfast and lunch and once between lunch and dinner and both will be consumed with an eight ounce bottle of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muffin control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>twenty four participants will be randomly selected to make up the muffin control group, in which one 120kcal muffin control snack will be consumed twice each day for eight weeks. The muffin control will be consumed one between breakfast and lunch and one between lunch and dinner, each snack will be consumed with an eight ounce bottled water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dried apples</intervention_name>
    <description>120 calories</description>
    <arm_group_label>Apple group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>muffin</intervention_name>
    <description>120 calories</description>
    <arm_group_label>Muffin control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must be between age 10-16&#xD;
&#xD;
          -  must be overweight or obese according to growth charts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  regular consumers of apples (one per day)&#xD;
&#xD;
          -  supplement users other than multivitamin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shirin Hooshmand, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Diego State Univeristy</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92182</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Dr. Shirin Hooshmand</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>apple</keyword>
  <keyword>high fiber</keyword>
  <keyword>body composition</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT02217124
org study id: S17213
nct id: NCT02217124
lead sponsor: 
has dmc: Yes
The primary objective of the proposed research is to determine the influence of 8 weeks of
      twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat
      120kcal muffin on components of obesity (waist circumference [waist measurement], serum
      glucose [blood sugar], triglycerides [fats in the blood] and HDL-cholesterol, and blood
      pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight
      and obese individuals. A total of 48 children aged 10-16 years will be randomly assigned to
      groups and provided with twice daily 120 kcal servings of either dried apples or muffins for
      8 weeks of feeding. Prior to initiating the feeding trial and again after 8 weeks, blood
      samples will be collected and analyzed. During each visit to the lab, subjects will be
      weighed in minimal clothing, tested for body composition using dual energy X-ray
      absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography (Bod
      Pod) and blood pressure, and measured for waist circumference. One 24-hour recall will be
      performed prior to initiation of the study; one recall will be performed throughout the
      feeding period, and one at the end of the 8 weeks. Dietary intake of energy, macronutrients,
      vitamins and minerals will be assessed to determine diet quality. All food records will be
      analyzed using the Nutritionist Pro (First DataBank) software. The potential benefits of the
      study include determining the effects of consistent snacking and particular snack foods on
      metabolism and weight management. There are no major risks to subjects in this study. There
      are minimal risks when performing venipuncture (blood draws) including bruising, perforation
      of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of
      needles, and infection. This study will hopefully allow more understanding and insight into
      the diet of children and the effect of it on body makeup and blood sugar. It is hypothesized
      that the twice a day apple snack group will have decreased waist circumference, body
      adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at
      the end of 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change from baseline Body Composition at 8 weeks
time frame: baseline, 8 weeks
description: Height, Weight, waist circumference, Body Mass Index are all used to asses body composition. Bod pod, BIA, and Dexa are also used to obtain the body composition.
measure: Change from baseline of triglycerides at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline blood glucose at 8 weeks
time frame: baseline, 8 weeks
description: Used to examine glucose regulation as effected by the apple group intervention.
arm group label: Apple group
arm group type: Experimental
description: twenty four participants will be randomly selected for the apple group, in which they will receive 37.5 grams equal to 120kcal of dried apples twice a day for eight weeks. This snack of apples will be eaten once between breakfast and lunch and once between lunch and dinner and both will be consumed with an eight ounce bottle of water.
arm group label: Muffin control
arm group type: Placebo Comparator
description: twenty four participants will be randomly selected to make up the muffin control group, in which one 120kcal muffin control snack will be consumed twice each day for eight weeks. The muffin control will be consumed one between breakfast and lunch and one between lunch and dinner, each snack will be consumed with an eight ounce bottled water.
intervention type: Other
intervention name: dried apples
description: 120 calories
arm group label: Apple group
intervention type: Other
intervention name: muffin
description: 120 calories
arm group label: Muffin control
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shirin Hooshmand, PhD
role: Principal Investigator
affiliation: San Diego State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Dr. Shirin Hooshmand
investigator title: Assistant Professor
mesh term: Obesity