A Novel Iron Supplement for Athletes: Phase I

University of Calgary

Status: Completed

Conditions: Diarrhea; Cramp, Abdominal; Constipation; Bleeding Gastric

Treatments: Dietary Supplement: FeSC

Study type: Interventional

Funder types: Other

Identifiers

NCT06285851

23-0825

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• cis-gendered female 18-25years old
• BMI <25 kg/m2
• engaging in moderate to vigorous physical activity for ≥3 hours per week

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

FeSC Cookie

Experimental group

Description:

Iron-yeast complex

Treatment:

Dietary Supplement: FeSC