A Novel Iron Supplement for Athletes: Phase I

Constipation Clinical Trial

Official title:

Pilot Study for a Novel Iron-Based Supplement for Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06285851
• Other study ID #: 23-0825
• Status: Completed
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: December 12, 2023

Study information

• Verified date: March 2024
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Gastric
• Colic
• Constipation
• Diarrhea

Intervention

Dietary Supplement:
• FeSC
Supplement

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Lallemand Bio-Ingredients

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI Symptoms	Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)	Daily for 14 days
Primary	Gastrointestinal symptoms	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)	Weekly for 14 days
Secondary	Supplement Tolerability and Preferences Questionnaire	Consumer preferences compared to standard of care (rating scale 0-4, where 0=not at all and 4=very much)	14 days
Secondary	Recovery	The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always)	14 days