Exploring tolerance and side effects of an innovative yeast-bound iron supplement: a feasibility trial.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Pilot and Feasibility Studies Pub Date : 2025-08-15 DOI:10.1186/s40814-025-01690-w

Keely A Shaw, Thomas A Tompkins, Brendan Abrahamson-Durant, Gillian MacNevin, Jill A Parnell, Martin J MacInnis, Raylene A Reimer, Jane Shearer

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引用次数: 0

Abstract

Background: Iron deficiency is prevalent among female athletes, often leading to fatigue, impaired recovery, and decreased performance. Conventional oral iron supplements are associated with poor absorption and negative gastrointestinal side effects, resulting in low adherence. This feasibility trial investigated the tolerability and gastrointestinal effects of an iron-yeast complex (FeSC) supplement in physically active females to assess its potential for further study.

Methods: This single-arm, mixed-methods feasibility trial recruited 14 active females (18-25 years) who consumed FeSC-fortified cookies (40 mg elemental iron) every other day for 14 days. Gastrointestinal symptoms, stress, and recovery were assessed through daily and weekly questionnaires (daily questionnaires: Gastrointestinal Symptoms Questionnaire and Short Recovery and Stress Scale; weekly questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scale; RESTQ Basic-24). Qualitative data on supplement acceptability were collected post-intervention. Feasibility was evaluated based on recruitment, retention, adherence, and safety criteria.

Results: Out of 52 participants who completed our screening questionnaire, 14 (age = 22 SD 2 years; weekly physical activity = 420 SD 140 min/week) met all criteria and completed the intervention. All feasibility criteria were met, including 100% retention, adherence, and questionnaire completion rates. Participants reported good supplement tolerability, with only a few cases of mild, transient gastrointestinal symptoms. A reduction in constipation symptoms compared to baseline and a reduction in diarrhea symptoms on days cookies were consumed compared to days they were not were observed. No serious adverse events occurred. While some participants noted a metallic aftertaste, 57% indicated that they would prefer the supplement in cookie form over traditional iron pills if given the choice.

Conclusions: This study demonstrates the feasibility and tolerability of FeSC supplementation in active females, with potential gastrointestinal benefits. Findings support progression to a larger trial assessing FeSC's impact on iron status and long-term adherence.

Trial registration: ClinicalTrials.gov NCT06285851. Registered on January 30, 2024.

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探索一种创新酵母结合铁补充剂的耐受性和副作用：可行性试验。

背景：缺铁在女运动员中很普遍，经常导致疲劳、恢复受损和表现下降。传统的口服铁补充剂与吸收不良和负面胃肠道副作用有关，导致低依从性。这项可行性试验研究了铁酵母复合物（FeSC）补充剂在体力活动女性中的耐受性和胃肠道效应，以评估其进一步研究的潜力。方法：这项单臂、混合方法可行性试验招募了14名活跃的女性（18-25岁），她们每隔一天食用fesc强化饼干（40毫克元素铁），持续14天。通过每日和每周问卷(每日问卷：胃肠症状问卷和短期恢复与压力量表；每周问卷调查：患者报告结果测量信息系统（PROMIS）胃肠道症状量表；RESTQ Basic-24)。干预后收集补充品可接受性的定性数据。可行性根据招募、保留、依从性和安全性标准进行评估。结果：在完成筛选问卷的52名参与者中，14名(年龄= 22 SD 2岁；每周体力活动= 420 SD 140分钟/周)符合所有标准并完成干预。所有的可行性标准均得到满足，包括100%的保留率、依从性和问卷完成率。参与者报告了良好的补充耐受性，只有少数病例出现轻微的、短暂的胃肠道症状。与基线相比，便秘症状减轻，与不吃饼干的日子相比，吃饼干的日子腹泻症状减轻。未发生严重不良事件。虽然一些参与者注意到金属的余味，但57%的人表示，如果可以选择，他们更喜欢饼干形式的补充剂，而不是传统的铁丸。结论：本研究证明了在运动女性中补充FeSC的可行性和耐受性，并具有潜在的胃肠道益处。研究结果支持进行更大规模的试验，评估FeSC对铁状态和长期依从性的影响。试验注册：ClinicalTrials.gov NCT06285851。注册于2024年1月30日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)

CiteScore

2.70

自引率

5.90%

发文量

241

审稿时长

9 weeks

期刊介绍： Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.