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How Does a Synbiotic Supplement Affect Iron Status During Iron Repletion in Iron Depleted Female Athletes?

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ClinicalTrials.gov Identifier: NCT03793959
Recruitment Status : Completed
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Marywood University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Iron-deficiency Dietary Supplement: Synbiotic Supplement Dietary Supplement: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: How Does a Synbiotic Supplement Affect Iron Status During Iron Repletion in Iron Depleted Female Athletes?
Actual Study Start Date : August 28, 2016
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Synbiotic Supplement
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.
Dietary Supplement: Synbiotic Supplement
Other Name: Regular Girl

Placebo Comparator: Placebo Supplement
Daily placebo supplement (5g maltodextrin, identical to Experimental -- white powder), along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Iron status [ Time Frame: 8 weeks ]
    Change in serum ferritin



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female, >18 y of age, athlete at Marywood University, passed NCAA-required medical screening (e.g. healthy enough to participate in sport).

Exclusion Criteria:

  • Current, acute, chronic illness; severe asthma; pre-existing GI disorders known to affect iron status or aggravated by iron supplementation; not pregnant or breastfeeding; clinically-diagnosed with eating disorder; consuming iron supplement within 4 weeks of screening; hemolytic anemia, excessive alcohol consumption.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793959


Locations
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United States, Pennsylvania
Marywood University
Scranton, Pennsylvania, United States, 18509
Sponsors and Collaborators
Marywood University

Publications:
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Responsible Party: Marywood University
ClinicalTrials.gov Identifier: NCT03793959     History of Changes
Other Study ID Numbers: 808959-2
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marywood University:
female athletes
iron supplementation
prebiotic
probiotic
synbiotic
serum ferritin
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs