<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/NCT03793959</url>
  </required_header>
  <id_info>
    <org_study_id>808959-2</org_study_id>
    <nct_id>NCT03793959</nct_id>
  </id_info>
  <brief_title>How Does a Synbiotic Supplement Affect Iron Status During Iron Repletion in Iron Depleted Female Athletes?</brief_title>
  <official_title>How Does a Synbiotic Supplement Affect Iron Status During Iron Repletion in Iron Depleted Female Athletes?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marywood University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marywood University</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>
      Iron deficiency (ID) affects ~30% of female athletes, and its consequences are highly&#xD;
      relevant to athletic performance. Poor iron (Fe) uptake remains a major factor in the&#xD;
      development of ID. While animal studies suggest that prebiotics may improve Fe uptake, this&#xD;
      has not been well-studied in humans. The main objective of the proposed study is to determine&#xD;
      the effects of synbiotic supplementation on the Fe status of ID female athletes during Fe&#xD;
      repletion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iron deficiency (ID) affects ~30% of female athletes, and its consequences are highly&#xD;
      relevant to athletic performance. Poor iron (Fe) uptake remains a major factor in the&#xD;
      development of ID. While animal studies suggest that prebiotics may improve Fe uptake, this&#xD;
      has not been well-studied in humans. The main objective of the proposed study is to determine&#xD;
      the effects of synbiotic supplementation on the Fe status of ID female athletes during Fe&#xD;
      repletion. At the beginning of a training season at a Division III University, the Fe status&#xD;
      of 28 female athletes (cross-country, lacrosse, basketball, field hockey) was screened.&#xD;
      Twenty eligible athletes (baseline Hgb:12.3±0.9g/dL; sFer:18.1±9.2µg/L) were then randomized&#xD;
      to receive either a daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic&#xD;
      B. lactis) or placebo, along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks using a&#xD;
      double-blind design. Fe status and body composition were assessed at baseline, mid-point and&#xD;
      after the trial. Participants were instructed to keep daily logs of supplement intake,&#xD;
      physical activity, GI and other symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2016</start_date>
  <completion_date type="Actual">December 8, 2017</completion_date>
  <primary_completion_date type="Actual">December 8, 2017</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>Twenty eligible athletes (baseline Hgb:12.3±0.9g/dL; sFer:18.1±9.2µg/L) were then randomized to receive either a daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic B. lactis) or placebo, along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks using a double-blind design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Iron status</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in serum ferritin</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Iron-deficiency</condition>
  <arm_group>
    <arm_group_label>Synbiotic Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic B. lactis, identical to Placebo-- white powder), along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Supplement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily placebo supplement (5g maltodextrin, identical to Experimental -- white powder), along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Synbiotic Supplement</intervention_name>
    <arm_group_label>Synbiotic Supplement</arm_group_label>
    <other_name>Regular Girl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo Supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, &gt;18 y of age, athlete at Marywood University, passed NCAA-required medical&#xD;
             screening (e.g. healthy enough to participate in sport).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current, acute, chronic illness; severe asthma; pre-existing GI disorders known to&#xD;
             affect iron status or aggravated by iron supplementation; not pregnant or&#xD;
             breastfeeding; clinically-diagnosed with eating disorder; consuming iron supplement&#xD;
             within 4 weeks of screening; hemolytic anemia, excessive alcohol consumption.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marywood University</name>
      <address>
        <city>Scranton</city>
        <state>Pennsylvania</state>
        <zip>18509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>DellaValle DM, Haas JD. Iron supplementation improves energetic efficiency in iron-depleted female rowers. Med Sci Sports Exerc. 2014 Jun;46(6):1204-15. doi: 10.1249/MSS.0000000000000208.</citation>
    <PMID>24195864</PMID>
  </reference>
  <reference>
    <citation>DellaValle DM. Iron supplementation for female athletes: effects on iron status and performance outcomes. Curr Sports Med Rep. 2013 Jul-Aug;12(4):234-9. doi: 10.1249/JSR.0b013e31829a6f6b. Erratum In: Curr Sports Med Rep. 2013 Sep-Oct;12(5):349.</citation>
    <PMID>23851410</PMID>
  </reference>
  <reference>
    <citation>Dellavalle DM, Haas JD. Iron status is associated with endurance performance and training in female rowers. Med Sci Sports Exerc. 2012 Aug;44(8):1552-9. doi: 10.1249/MSS.0b013e3182517ceb.</citation>
    <PMID>22382172</PMID>
  </reference>
  <reference>
    <citation>DellaValle DM, Haas JD. Impact of iron depletion without anemia on performance in trained endurance athletes at the beginning of a training season: a study of female collegiate rowers. Int J Sport Nutr Exerc Metab. 2011 Dec;21(6):501-6. doi: 10.1123/ijsnem.21.6.501.</citation>
    <PMID>22089308</PMID>
  </reference>
  <reference>
    <citation>Laparra JM, Diez-Municio M, Herrero M, Moreno FJ. Structural differences of prebiotic oligosaccharides influence their capability to enhance iron absorption in deficient rats. Food Funct. 2014 Oct;5(10):2430-7. doi: 10.1039/c4fo00504j. Epub 2014 Aug 11.</citation>
    <PMID>25109275</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>female athletes</keyword>
  <keyword>iron supplementation</keyword>
  <keyword>prebiotic</keyword>
  <keyword>probiotic</keyword>
  <keyword>synbiotic</keyword>
  <keyword>serum ferritin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03793959
org study id: 808959-2
nct id: NCT03793959
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Iron deficiency (ID) affects ~30% of female athletes, and its consequences are highly
      relevant to athletic performance. Poor iron (Fe) uptake remains a major factor in the
      development of ID. While animal studies suggest that prebiotics may improve Fe uptake, this
      has not been well-studied in humans. The main objective of the proposed study is to determine
      the effects of synbiotic supplementation on the Fe status of ID female athletes during Fe
      repletion.
Iron deficiency (ID) affects ~30% of female athletes, and its consequences are highly
      relevant to athletic performance. Poor iron (Fe) uptake remains a major factor in the
      development of ID. While animal studies suggest that prebiotics may improve Fe uptake, this
      has not been well-studied in humans. The main objective of the proposed study is to determine
      the effects of synbiotic supplementation on the Fe status of ID female athletes during Fe
      repletion. At the beginning of a training season at a Division III University, the Fe status
      of 28 female athletes (cross-country, lacrosse, basketball, field hockey) was screened.
      Twenty eligible athletes (baseline Hgb:12.3±0.9g/dL; sFer:18.1±9.2µg/L) were then randomized
      to receive either a daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic
      B. lactis) or placebo, along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks using a
      double-blind design. Fe status and body composition were assessed at baseline, mid-point and
      after the trial. Participants were instructed to keep daily logs of supplement intake,
      physical activity, GI and other symptoms.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Twenty eligible athletes (baseline Hgb:12.3±0.9g/dL; sFer:18.1±9.2µg/L) were then randomized to receive either a daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic B. lactis) or placebo, along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks using a double-blind design.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Iron status
time frame: 8 weeks
description: Change in serum ferritin
arm group label: Synbiotic Supplement
arm group type: Experimental
description: Daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic B. lactis, identical to Placebo-- white powder), along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks.
arm group label: Placebo Supplement
arm group type: Placebo Comparator
description: Daily placebo supplement (5g maltodextrin, identical to Experimental -- white powder), along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks.
intervention type: Dietary Supplement
intervention name: Synbiotic Supplement
arm group label: Synbiotic Supplement
other name: Regular Girl
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo Supplement
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: DellaValle DM, Haas JD. Iron supplementation improves energetic efficiency in iron-depleted female rowers. Med Sci Sports Exerc. 2014 Jun;46(6):1204-15. doi: 10.1249/MSS.0000000000000208.
PMID: 24195864
citation: DellaValle DM. Iron supplementation for female athletes: effects on iron status and performance outcomes. Curr Sports Med Rep. 2013 Jul-Aug;12(4):234-9. doi: 10.1249/JSR.0b013e31829a6f6b. Erratum In: Curr Sports Med Rep. 2013 Sep-Oct;12(5):349.
PMID: 23851410
citation: Dellavalle DM, Haas JD. Iron status is associated with endurance performance and training in female rowers. Med Sci Sports Exerc. 2012 Aug;44(8):1552-9. doi: 10.1249/MSS.0b013e3182517ceb.
PMID: 22382172
citation: DellaValle DM, Haas JD. Impact of iron depletion without anemia on performance in trained endurance athletes at the beginning of a training season: a study of female collegiate rowers. Int J Sport Nutr Exerc Metab. 2011 Dec;21(6):501-6. doi: 10.1123/ijsnem.21.6.501.
PMID: 22089308
citation: Laparra JM, Diez-Municio M, Herrero M, Moreno FJ. Structural differences of prebiotic oligosaccharides influence their capability to enhance iron absorption in deficient rats. Food Funct. 2014 Oct;5(10):2430-7. doi: 10.1039/c4fo00504j. Epub 2014 Aug 11.
PMID: 25109275
responsible party type: Sponsor
mesh term: Iron Deficiencies
sharing ipd: Undecided