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临床试验/NCT04526678
NCT04526678已完成不适用

Iron Intake, Iron Status, Intestinal Health and Endurance Performance - Effects of Iron Supplementation in Young Female Football Players - a Pilot Study

Norwegian University of Life Sciences1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年8月19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
发起方
入组人数
23
试验地点
1
主要终点
Diet composition

研究概览

简要总结

The aim of the study is to characterize the diet and iron status of young female elite football players and examine the relationship between iron intake, iron status, hemoglobin levels, intestinal health and sports performance. In addition, the effects of low-dose iron supplements on iron stores will be investigated and whether such supplementation affects intestinal health, microbiota composition and biomarkers for oxidative stress.

详细描述

Iron deficiency can lead to fatigue and anemia. Because iron is necessary for the formation of new blood cells (hematopoiesis), it is an extensive practice internationally among athletes to take iron supplements in the belief that this will improve endurance performance and oxygen transport capacity by increasing red blood cell production. Although iron intake in menstruating women has shown to reduce the prevalence of anemia and iron deficiency as well as increasing hemoglobin values and iron stores. However iron supplementation increases the risk of iron excess and can result in undesirable effects such as constipation and abdominal pain as well as negative impact on intestinal epithelial permeability and increase in oxidative stress. Because iron is important for the replication and survival of almost all bacteria, with few exceptions, the intake of iron also affect the composition of the intestinal bacteria. Not surprisingly, both high and low iron levels affect the composition of the microbiota in the gut.

It is not known if young menstruating Norwegian female athletes cover their need for iron via the diet or whether extra intake in the form of a low-dose supplement could be beneficial in terms of hemoglobin levels and sports performance. Because iron preparations are not prescription and are sold in pharmacies, health food stores and larger grocery stores, this can lead to uncritical intake of iron. Since the use of iron preparations has been documented to be widespread in foreign sports environments, it is important to both characterize the iron status of Norwegian athletes and at the same time examine the beneficial value of iron supplements on sports performance as well as monitoring effects on microbiota composition and intestinal health.

The aim of the study is therefore to characterize the diet and iron status of young female elite football players and examine the relationship between iron intake, iron status, hemoglobin levels, intestinal health and sports performance. In addition, the effects of low-dose iron supplements will be investigated in relation to iron stores, hemoglobin levels and sports performance and whether such supplementation affects intestinal health, microbiota composition and biomarkers for oxidative stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

The assessor of outcomes are blinded to group allocation.

入排标准

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

入选标准

  • •- Female elite football players from two selected football clubs

排除标准

  • •Pregnancy
  • •Medical conditions that are worsened by taking iron supplements
  • •Already taking iron supplements

研究组 & 干预措施

Control group

No Intervention

The control group will not ingest iron supplements.

Iron supplements

Experimental

The intervention group will ingest 27 mg iron supplement per day for three months while the control group will not ingest iron supplements.

干预措施: Iron supplement (27mg) (Dietary Supplement)

结局指标

主要结局

Diet composition

时间窗: 3 months

Diet composition will be assessed using digital 7 day dietary records.

Iron intake

时间窗: 3 months

Iron intake will be calculated based on average daily intake of iron according to the digital 7 day dietary recordings.

Serum Iron

时间窗: 3 months

Iron status will be assessed by analyzing serum iron (µmol/L)

Serum transferrin

时间窗: 3 months

Iron status will be assessed by analyzing serum transferrin (µmol/L)

Serum ferritin

时间窗: 3 months

Iron status will be assessed by analyzing serum ferritin (µg/L)

Hemoglobin levels

时间窗: 3 months

hemoglobin (Hb) (g/dl) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.

LPS binding protein

时间窗: 3 months

-Intestinal health will be measured using biomarkers of intestinal leakage in serum and feces such as sLPS binding protein (LBP) (ug/ml)

Neutrophil gelatinase-associated lipocalin

时间窗: 3 months

-Intestinal health will be measured using biomarkers of intestinal leakage in serum and feces such as fecal neutrophil gelatinase-associated lipocalin (NGAL) (ng/g feces)

Serum cytokines

时间窗: 3 months

-Intestinal health will be measured using serum biomarkers of systemic inflammation (e.g. serum cytokines such as IL-1, IL-6, and TNF-α pg/ml).

Sports performance

时间窗: 3 months

Sports performance specific for football will be be measured using the Yo-Yo Intermittent Recovery Test (YYIR1).

Differential counts

时间窗: 3 months

Differential counts (% of WBC) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.

Ferric reducing ability of plasma

时间窗: 3 months

-Oxidative stress will be assessed measuring the ferric reducing ability of plasma (FRAP)

Diacron reactive oxygen metabolites

时间窗: 3 months

-Oxidative stress will be assessed measuring biomarkers of total oksidativ stress e.g. diacron reactive oxygen metabolites (dROM).

Microbiota composition

时间窗: 3 months

-Microbiota composition will be analyzed mainly using 16S rRNA gene sequencing. The main effect of the intervention on the microbiota will be tested based on crude alpha and beta diversity indices but we will also apply advanced multivariate methods.

次要结局

未报告次要终点

研究者

发起方
Norwegian University of Life Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Siv K Bohn

Professor

Norwegian University of Life Sciences

研究点 (1)

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