Pilot Study for a Novel Iron-Based Supplement for Athletes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- GI Symptoms
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 is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance.
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, the investigators have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the tolerability of the developed supplement and any associated symptoms before conducting a clinical trial on this product. Participants will consume 40mg of elemental iron every second day for 14 days. Participants will complete a daily survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms. Additionally, participants will complete a more thorough survey of gastrointestinal symptoms at baseline, the mid-point, and the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •BMI <25 kg/m2
- •engaging in moderate to vigorous physical activity for ≥3 hours per week
排除标准
- •gastrointestinal issues (e.g. Irritable bowel disease/syndrome)
- •chronic illnesses
- •prescription medication (including oral contraceptives)
- •allergies to supplement ingredients
- •iron supplementation in the last 3 months
结局指标
主要结局
GI Symptoms
时间窗: Daily for 14 days
Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)
Gastrointestinal symptoms
时间窗: Weekly for 14 days
Patient-Reported Outcomes Measurement Information System (rating scale 0-4 where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much)
次要结局
- Recovery(14 days)
- Supplement Tolerability and Preferences Questionnaire(14 days)
研究者
Jane Shearer
Principal Investigator
University of Calgary