ConstipationNCT06285851
A Novel Iron Supplement for Athletes: Phase I
A study testing FeSC in people with Constipation and Diarrhea, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation, Diarrhea, Cramp, Abdominal
- What is being tested?
- FeSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2023to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- cis-gendered female 18-25years old
- BMI <25 kg/m2
- engaging in moderate to vigorous physical activity for ≥3 hours per week
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for a Novel Iron-Based Supplement for Athletes
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.
Read the 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 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.
- Conditions
- Constipation, Diarrhea, Cramp, Abdominal, Bleeding Gastric
- Being tested
- FeSC
- Medical subject headings
- Constipation, Diarrhea, Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeSCDietary supplement
Supplement
| Study group | Role | What they receive |
|---|---|---|
| FeSC Cookie | Experimental | Iron-yeast complex Receives: Dietary Supplement: FeSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Symptoms
Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)
Measured: Daily for 14 days
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)
Measured: Weekly for 14 days
Secondary outcomes (2)
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)
Measured: 14 days
Recovery
The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start23 Nov 2023
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Bio-Ingredients
- Responsible party
- Principal investigator, Jane Shearer, University of Calgary
- Investigators
- Jane Shearer, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285851
- Sponsor's protocol ID
- 23-0825
- Status last verified
- Mar 2024
- First submitted
- 30 Jan 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaw KA, Tompkins TA, Abrahamson-Durant B, MacNevin G, Parnell JA, MacInnis MJ, Reimer RA, Shearer J. Exploring tolerance and side effects of an innovative yeast-bound iron supplement: a feasibility trial. Pilot Feasibility Stud. 2025 Aug 15;11(1):110. doi: 10.1186/s40814-025-01690-w.
PubMed 40817080
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for a Novel Iron-Based Supplement for Athletes
- ClinicalTrials.gov ID
- NCT06285851
- Acronym / sponsor ID
- 23-0825
- Conditions
- Constipation, Diarrhea, Cramp, Abdominal, Bleeding Gastric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Lallemand Bio-Ingredients
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FeSC Cookie | Experimental | Dietary Supplement: FeSCIron-yeast complex |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- cis-gendered female 18-25years old
- BMI <25 kg/m2
- engaging in moderate to vigorous physical activity for ≥3 hours per week
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeSCSupplement | Dietary supplement | FeSC Cookie |
Primary outcome
GI Symptoms
Time frame: Daily for 14 days
Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)
Gastrointestinal symptoms
Time frame: Weekly for 14 days
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)
2 secondary outcomes
Supplement Tolerability and Preferences Questionnaire
Time frame: 14 days
Recovery
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 40817080Shaw KA, Tompkins TA, Abrahamson-Durant B, MacNevin G, Parnell JA, MacInnis MJ, Reimer RA, Shearer J. Exploring tolerance and side effects of an innovative yeast-bound iron supplement: a feasibility trial. Pilot Feasibility Stud. 2025 Aug 15;11(1):110. doi: 10.1186/s40814-025-01690-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Shearer, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FeSC in people with Constipation and Diarrhea, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI Symptoms (time frame: Daily for 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06285851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.