A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II

U

University of Calgary

Status

Not yet enrolling

Conditions

Iron Deficiencies

Treatments

Other: FeSC

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06269913
23-0826

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Iron/yeast complex (FeSC)
Experimental group
Description:
Iron Supplement
Treatment:
Other: FeSC

Trial contacts and locations

0

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Central trial contact

Keely Shaw, Ph.D.

Data sourced from clinicaltrials.gov

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