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临床试验/NCT03793959
NCT03793959已完成不适用

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

Marywood University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Iron status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Synbiotic Supplement (Dietary 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.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Iron status

时间窗: 8 weeks

Change in serum ferritin

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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