Novel Iron-Based Supplement for Active Young Women With Sub-Optimal Iron
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Iron Status
研究概览
简要总结
Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.
详细描述
Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, we have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in young, endurance-trained females with sub-optimal iron status. Participants will consume 40mg of elemental iron every second day for 8 weeks. Before and after supplementation,participants will be assessed for exercise capacity (VO2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •cis-gendered female 18-25years old
- •sub-optimal iron status (ferritin ≤45mcg/ L)
- •At least 1 year past the age of menarche
- •Engage in moderate to vigorous endurance activity for at least 3 hours a week
排除标准
- •Supplemented with iron iron (>5mg/day), prebiotics, or probiotics in last 3 months
- •antibiotic use in last 3 months
- •- Energy availability >30 kcal/kg lean body mass
研究组 & 干预措施
Iron/yeast complex (FeSC)
Iron Supplement
干预措施: FeSC (Other)
结局指标
主要结局
Iron Status
时间窗: 4 weeks, 8 weeks
Ferritin
Hemoglobin
时间窗: 4 weeks, 8 weeks
Hemoglobin concentration
Upper Gut Microbiome
时间窗: 4 weeks, 8 weeks
SIMBA capsule
Lower Gut microbiome
时间窗: 4 weeks, 8 weeks
Fecal sample
次要结局
- Exercise Capacity(8 weeks)
- Hemoglobin Mass(8 weeks)
- Gastrointestinal Symptoms 1(Weekly for 8 weeks)
研究者
Jane Shearer
Professor
University of Calgary