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

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793959
• Other study ID #: 808959-2
• Status: Completed
• Phase: N/A
• Start date: August 28, 2016
• Est. completion date: December 8, 2017

Study information

• Verified date: January 2019
• Source: Marywood University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

Dietary Supplement:
• Synbiotic Supplement

• Placebo

Locations

Country	Name	City	State
United States	Marywood University	Scranton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Marywood University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. Erratum in: Curr Sports Med Rep. 2013 Sep-Oct;12(5):349. — View Citation

Laparra JM, Díez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron status	Change in serum ferritin	8 weeks