NCT03793959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

January 3, 2019

Last Update Submit

January 3, 2019

Conditions

Iron-deficiency

Keywords

female athletesiron supplementationprebioticprobioticsynbioticserum ferritin

Outcome Measures

Primary Outcomes (1)

  • Iron status

    Change in serum ferritin

    8 weeks

Study Arms (2)

Synbiotic Supplement

EXPERIMENTAL

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

Placebo Supplement

PLACEBO COMPARATOR

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

Interventions

Synbiotic SupplementDIETARY_SUPPLEMENT
Also known as: Regular Girl
Synbiotic Supplement
PlaceboDIETARY_SUPPLEMENT
Placebo Supplement

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marywood University

Scranton, Pennsylvania, 18509, United States

Location

Related Publications (5)

  • 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: 24195864BACKGROUND

  • 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.

    PMID: 23851410BACKGROUND

  • 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: 22382172BACKGROUND

  • 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: 22089308BACKGROUND

  • 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: 25109275BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 4, 2019

Study Start

August 28, 2016

Primary Completion

December 8, 2017

Study Completion

December 8, 2017

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

US(1)