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临床试验/NCT03002090
NCT03002090已完成不适用

Defining the Functional and Metabolic Role of Iron in Aerobic Training and Physical Performance

Cornell University1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
1
主要终点
Concentration of serum ferritin in µg/L

研究概览

简要总结

Iron deficiency is known to negatively impact physical performance, attention, and time spent doing physical activity. As a result, an iron deficient person must expend more energy to complete the same amount of work as someone who is healthy. Another interesting relationship has been observed between exercise training and iron status in that women who participate in exercise training often have higher rates of iron deficiency than sedentary women. ID is commonly treated using daily iron supplementation. However, it is currently unknown whether participating in regular exercise somehow impacts the effectiveness of iron supplementation. Iron deficient women who participate in exercise programs may potentially benefit less from iron supplementation than those who do not. Another common treatment for the symptoms of iron deficiency is the traditional Chinese herbal treatment, Ba-Zhen-Ke-Li (BZKL). While studies have shown that BZKL impacts expression of some iron-related proteins and increases endurance performance in rats, no studies have examined the efficacy of BZKL in improving iron markers or physical performance in humans. This study will compare the efficacy of BZKL in improving iron status and physical performance with that of ferrous sulfate supplementation. The Cornell research team will achieve these objectives in collaboration with colleagues at Kunming Medical University (KMU) in Kunming, China. A double-blind, randomized, placebo controlled study will be conducted by a Cornell graduate student at KMU. The subjects will be healthy women, age 18-26 years, attending KMU. Blood samples will be collected and analyzed for measures of iron).

Subjects will be randomly assigned to receive 50 mg of ferrous sulfate (10 mg of elemental iron), 6mg of BZKL, or an identical placebo pill twice daily for 8 weeks. Subjects will be further randomly sub-divided to receive aerobic exercise training or no training during the 8-week supplementation period. At weeks 4 and 8, subjects will perform the same series of tests as was performed at baseline. The investigators hypothesize that: 1. the women who train and received iron will have smaller improvements in iron status than those who do not train 2. The women who receive iron and train will have greater improvements in physical performance than those who train and do not receive iron, and 3. The women who receive BZKL will improve their iron status or physical performance more than those who receive placebo.

详细描述

Background: Despite the overall improvements in malnutrition in the Chinese population, iron deficiency (ID) and iron deficiency anemia (low iron and low hemoglobin, IDA) are still widely prevalent in China. According to recent studies, the prevalence of anemia in Chinese women of childbearing age is 20% and can be as high as 30% in rural areas, with 85% of anemia cases resulting from ID. Diabetes, heart disease, and obesity are also highly prevalent in China - though the Chinese government is taking actions against these epidemics, often via interventions promoting physical activity. Iron deficiency without anemia (IDNA) can impair adult physical performance and lowers time spent doing voluntary physical activities. However, iron supplementation intended to alleviate IDNA may be less effective in those who are physically active, suggesting an intricate, but currently undefined, relationship between iron status, exercise, and physical performance capacity. A combined analysis of iron status, exercise training, and physical performance in Chinese women could illuminate interactions between these factors and their role in diabetes and obesity reduction.

One common treatment for the symptoms of iron deficiency is the traditional Chinese herbal treatment, Ba-Zhen-Ke-Li (BZKL). While studies have shown that BZKL impacts expression of some iron-related proteins and increases endurance performance in rats, no studies have examined the efficacy of BZKL in improving iron markers or physical performance in humans. This study will compare the efficacy of BZKL in improving iron status and physical performance with that of ferrous sulfate supplementation.

Significance and Specific Aims:

The goal of the proposed research is to clarify the relationship between iron status, physical performance, and aerobic exercise training. By conducting an iron intervention study in combination with an exercise training program, the investigators can examine the modifying effect of iron status on the physical performance changes from aerobic exercise training as well as the modifying effect of participation in aerobic exercise in maintenance of iron status. To achieve this goal, a randomized double-blind, placebo controlled trial will be conducted with Chinese collegiate women.

The proposed work will be organized along three specific aims:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-26
  • Must be able to complete exercise on a stationary bicycle
  • Clinical diagnosis of iron depletion without severe anemia (sFer< 25µg/L, Hb>110g/L)
  • Willing to comply with the 8-week supplementation and if assigned, training program

排除标准

  • age less than 18
  • severe anemia (Hb<90g/L in blood analyses)
  • current pregnancy or pregnancy within the previous year
  • recent infectious illness or fever
  • current inflammation or chronic inflammatory diseases (AGP > 1.0 g/L in blood analyses)
  • hemolytic anemia
  • chronic respiratory disease
  • musculoskeletal problems
  • history of eating disorders
  • smoking, BMI < 18 or >24 kg/m2
  • consumption of medications that may affect dietary iron intake or absorption or that have anticoagulant properties
  • participation in varsity sports team

结局指标

主要结局

Concentration of serum ferritin in µg/L

时间窗: Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

Changes from week 0 to weeks 4 and 8 measured both within and between groups.

Concentration of hemoglobin g/L

时间窗: Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

Changes from week 0 to weeks 4 and 8 measured both within and between groups.

Concentration of soluble transferrin receptor in mg/L

时间窗: Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

Changes from week 0 to weeks 4 and 8 measured both within and between groups.

Concentration of alpha-1-acid glycoprotein in g/L

时间窗: Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

Changes from week 0 to weeks 4 and 8 measured both within and between groups.

Concentration of C-reactive protein in mg/L

时间窗: Change in concentration of the 5 biomarkers from weeks 0 to 8. Change in concentration of the 5 biomarkers from weeks 0 to 4.

Changes from week 0 to weeks 4 and 8 measured both within and between groups.

次要结局

  • Human performance as assessed by maximal capacity for oxygen uptake (mL/min/kg body weight)(Change from weeks 0 to 8. Change from weeks 0 to 4.)
  • Human performance as assessed by energetic efficiency (in %)(Change from weeks 0 to 8. Change from weeks 0 to 4.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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