Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338787
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-24
Brief Title:
A Novel Iron-Based Supplement for Athletes Aged 14-17
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Novel Iron-Based Supplement for Active Young Women With Sub-Optimal Iron
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 efficacy of a yeast-iron complex in improving iron status gut microbiome and exercise performance in endurance-trained adolescent females aged 14-17 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 which they will report feelings of stress and recovery as well as gastrointestinal symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None