<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/NCT01660503</url>
  </required_header>
  <id_info>
    <org_study_id>Tate &amp; Lyle Teen Study</org_study_id>
    <nct_id>NCT01660503</nct_id>
  </id_info>
  <brief_title>Dose Effects of SCF on Calcium Metabolism and GI Microflora in Adolescents</brief_title>
  <official_title>Dose Response Effects of Soluble Corn Fiber (SCF) on Calcium Metabolism and Gastrointestinal Microflora in Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tate and Lyle Ingredients Americas LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in&#xD;
      rats and in adolescent boys and girls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The growing knowledge of non-digestible oligosaccharide (NDO)-related health benefits has led&#xD;
      to the identification of other fermentable carbohydrates which may improve bone balance and&#xD;
      bone health parameters. One such carbohydrate is the corn derivative, soluble corn fiber&#xD;
      (SCF). Already known for its association with improved intestinal health and influence on&#xD;
      colonic microflora content, we have been studying the effects of SCF on calcium absorption&#xD;
      and bone health. First we found that soluble corn fiber (SCF) greatly enhanced calcium&#xD;
      utilization and bone properties in a growing rat model. Results from this study demonstrated&#xD;
      that SCF was capable of increasing bone mineral content, density and bone strength parameters&#xD;
      in 4-week old, male rats. Our study in adolescent boys and girls showed a 12% increase in&#xD;
      calcium absorption after consuming 12 g SCF for 21 days compared to a control period in a&#xD;
      crossover design using a controlled feeding metabolic balance approach. Given these profound&#xD;
      changes on calcium absorption and in bone, a logical next step is to study a dose-response&#xD;
      effect of SCF on calcium absorption, bone turnover, and gut microflora in free-living&#xD;
      adolescents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">April 30, 2014</completion_date>
  <primary_completion_date type="Actual">April 30, 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Calcium Absorption</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The subject will be asked to consume one snack item in the morning and one snack in the evening for four consecutive weeks.&#xD;
After consuming the SCF product for four weeks the teen will come to Purdue University campus for 3 nights and days (e.g. Thursday noon - Sunday noon). They will reside in university residence hall or hotel near campus. Calcium Absorption testing will be done utilizing 43Ca and 44Ca.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GI microbial changes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fecal microbial analyses will be performed on a baseline sample collected before each 4 week consumption period to establish basal microbial profiles. Additional analyses will be performed on fecal samples collected during the 3 day clinical visit to compare microbial changes in response to SCF treatments.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>No SCF</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Twice daily consumption of snack foods containing no SCF.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 grams SCF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice daily consumption of snack foods, each containing 5 grams SCF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 grams SCF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice daily consumption of snack foods, each containing 10 grams SCF</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>0 grams SCF</intervention_name>
    <description>Given in snack foods (muffins and flavored beverage)</description>
    <arm_group_label>No SCF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>10 grams SCF</intervention_name>
    <description>Given in snack foods (muffins and flavored beverage)</description>
    <arm_group_label>10 grams SCF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>20 grams SCF</intervention_name>
    <description>Given in snack foods (muffins and flavored beverage)</description>
    <arm_group_label>20 grams SCF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adolescent Caucasian girls between the ages of 12-14. This population has been&#xD;
             chosen because they exhibit higher risk for osteoporosis later in life.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Habitual dietary patterns including less than 550 and greater than 1500 mg Ca per day.&#xD;
             This represents the 5th and 95th percentile of usual intake of girls 9-13 y in the US.&#xD;
&#xD;
          -  History of smoking, alcohol use, illegal or non-prescription drug use&#xD;
&#xD;
          -  History of disordered calcium or bone metabolism e.g. Paget's disease, hyper or&#xD;
             hypo-calcemia&#xD;
&#xD;
          -  History of gastrointestinal diseases (Crohn's, celiac, inflammatory bowel disease)&#xD;
&#xD;
          -  History of diseases that affect kidney or liver function.&#xD;
&#xD;
          -  Body Mass Index (BMI) less than 5th percentile for age or greater than the 90th&#xD;
             percentile for age&#xD;
&#xD;
          -  Having a broken bone within the last 6 months.&#xD;
&#xD;
          -  Regular consumption of foods or supplements containing prebiotics or probiotics&#xD;
&#xD;
          -  History of pregnancy or use of contraceptives&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Connie M Weaver, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Berdine R Martin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Berdine Martin</investigator_full_name>
    <investigator_title>Research Scientist, Nutrition Science</investigator_title>
  </responsible_party>
  <keyword>Calcium absorption</keyword>
  <keyword>Osteoporosis</keyword>
  <keyword>Bone Health</keyword>
  <keyword>Adolescent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</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/NCT01660503
org study id: Tate & Lyle Teen Study
nct id: NCT01660503
lead sponsor: 
collaborator: 
has dmc: No
Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in
      rats and in adolescent boys and girls.
The growing knowledge of non-digestible oligosaccharide (NDO)-related health benefits has led
      to the identification of other fermentable carbohydrates which may improve bone balance and
      bone health parameters. One such carbohydrate is the corn derivative, soluble corn fiber
      (SCF). Already known for its association with improved intestinal health and influence on
      colonic microflora content, we have been studying the effects of SCF on calcium absorption
      and bone health. First we found that soluble corn fiber (SCF) greatly enhanced calcium
      utilization and bone properties in a growing rat model. Results from this study demonstrated
      that SCF was capable of increasing bone mineral content, density and bone strength parameters
      in 4-week old, male rats. Our study in adolescent boys and girls showed a 12% increase in
      calcium absorption after consuming 12 g SCF for 21 days compared to a control period in a
      crossover design using a controlled feeding metabolic balance approach. Given these profound
      changes on calcium absorption and in bone, a logical next step is to study a dose-response
      effect of SCF on calcium absorption, bone turnover, and gut microflora in free-living
      adolescents.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Calcium Absorption
time frame: 4 Weeks
description: The subject will be asked to consume one snack item in the morning and one snack in the evening for four consecutive weeks.
After consuming the SCF product for four weeks the teen will come to Purdue University campus for 3 nights and days (e.g. Thursday noon - Sunday noon). They will reside in university residence hall or hotel near campus. Calcium Absorption testing will be done utilizing 43Ca and 44Ca.
measure: GI microbial changes
time frame: 4 weeks
description: Fecal microbial analyses will be performed on a baseline sample collected before each 4 week consumption period to establish basal microbial profiles. Additional analyses will be performed on fecal samples collected during the 3 day clinical visit to compare microbial changes in response to SCF treatments.
arm group label: No SCF
arm group type: Placebo Comparator
description: Twice daily consumption of snack foods containing no SCF.
arm group label: 10 grams SCF
arm group type: Experimental
description: Twice daily consumption of snack foods, each containing 5 grams SCF
arm group label: 20 grams SCF
arm group type: Experimental
description: Twice daily consumption of snack foods, each containing 10 grams SCF
intervention type: Dietary Supplement
intervention name: 0 grams SCF
description: Given in snack foods (muffins and flavored beverage)
arm group label: No SCF
intervention type: Dietary Supplement
intervention name: 10 grams SCF
description: Given in snack foods (muffins and flavored beverage)
arm group label: 10 grams SCF
intervention type: Dietary Supplement
intervention name: 20 grams SCF
description: Given in snack foods (muffins and flavored beverage)
arm group label: 20 grams SCF
criteria: 
gender: Female
minimum age: 9 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Connie M Weaver, Ph.D.
role: Principal Investigator
affiliation: Purdue University
last name: Berdine R Martin, PhD
role: Study Director
affiliation: Purdue University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Berdine Martin
investigator title: Research Scientist, Nutrition Science
mesh term: Osteoporosis