Active not recruitingNAINTERVENTIONAL

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

This study is investigating a new type of iron supplement designed for female athletes aged 18-25 who often have low iron. Many existing iron pills can cause side effects like stomach problems, so researchers have developed a new version that might be gentler. The aim is to see if this new supplement can improve iron levels, enhance the helpful bacteria in the gut, and ultimately boost sports performance in these young women. Participants will take the supplement for 8 weeks, and their iron, gut health, and fitness will be checked before and after. They'll also share weekly updates on how they're feeling.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Calgary

Enrolment target

Start

17 Jun 2024

Estimated completion

01 Dec 2025

Iron Deficiencies

What is this study about?

Team Patient.info has learned about an exciting new study focusing on iron levels in young female athletes. Many athletes, especially women, can struggle with low iron, which can make them feel tired and affect how well they perform in their sport. The problem is that many common iron supplements can cause uncomfortable side effects like tummy aches, sickness, or constipation. This often makes people stop taking them.

Because of these issues, researchers have created a new kind of iron supplement. This study will be testing this new supplement to see if it's better tolerated and more effective than current options. They want to find out if it can successfully raise iron levels, improve the balance of healthy bacteria in the gut, and help athletes perform better without causing the usual side effects.

The study involves young women who are aged 18 to 25 and regularly take part in endurance sports. If successful, this new supplement could offer a much-needed alternative for athletes to manage their iron levels and stay at the top of their game.

Key takeaways

A new iron supplement is being tested for young female athletes.
It aims to reduce stomach upset often caused by current iron pills.
The study wants to improve iron, gut health, and sports performance.
Participation involves taking a pill for 8 weeks and having health checks.
It's for women aged 18-25 who do endurance sports and have low iron.

Who may be eligible?

This study is looking for young women between the ages of 18 and 25. You should have already had your periods for several years and regularly take part in endurance sports, like long-distance running or cycling, for at least three hours a week.

To join, you need to have slightly low iron levels, but not extremely low. This will be checked by the study team. You also shouldn't have taken other iron supplements (more than a tiny amount), special gut health supplements called prebiotics or probiotics, or antibiotics in the last three months.

There are also some requirements about your body's energy levels that the research team will check to make sure the study is right for you. If you meet these general criteria, the study team can let you know if you're a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 18 and 25 years old?
Have you been having periods for at least one year?
Do you do at least 3 hours of moderate to intense endurance exercise per week?
Have you avoided iron supplements (more than 5mg/day), prebiotics, probiotics, or antibiotics in the last three months?
Are you generally healthy, with no major health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to take one special iron supplement pill every other day for 8 weeks. Before you start taking anything, and again after the 8 weeks, you'll have some check-ups. These will include tests to measure your fitness (like how well your body uses oxygen during exercise), your iron levels, and the health of the helpful bacteria in your gut. During the 8 weeks of taking the supplement, you'll also fill out a short online survey every week. This survey will ask about how stressed you feel, how well you're recovering from exercise, and if you're experiencing any tummy troubles. The total duration of your active involvement in the study will be about 8 weeks, plus the initial and final assessment visits.

Potential risks and benefits

Taking part in this study could potentially help improve your iron levels, gut health, and sports performance, especially if current iron supplements cause you unpleasant side effects. As with any new treatment, there's always a chance you might experience some unexpected effects. However, the researchers are very focused on your well-being, and they will carefully monitor you for any problems. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Calgary
Verified postcode
Calgary, Canada

Common questions

What is 'sub-optimal iron status'?

This means your iron levels are a bit lower than ideal, but not so low that you would be diagnosed with very severe iron deficiency.

What kind of sports count as 'endurance activity'?

This typically includes activities like running, cycling, swimming, or rowing for longer periods. The study team can clarify if your specific sport qualifies.

What does 'gut microbiome' mean?

This refers to all the good and bad bacteria, viruses, and other tiny living things that live in your gut and help with digestion and other body functions.

Will I know if I'm getting the new iron supplement or a dummy pill?

The information provided suggests everyone in this phase will get the new iron supplement. However, the study team can provide full details on this.

How much time will this study take up each week?

Mainly just filling out a short weekly survey, plus the initial and final assessment visits which will be longer.