Active not recruitingNAINTERVENTIONAL

A Novel Iron-Based Supplement for Athletes Aged 14-17

This study is for young female athletes (aged 14 to 17) who take part in endurance sports and might have low iron levels. Many iron supplements can cause side effects like stomach pain or sickness. This research is testing a new type of iron supplement that aims to avoid these problems. The main goal is to see if this new iron supplement can improve iron levels, help their gut health (their 'gut microbiome'), and make them perform better during exercise. It's hoped this new supplement will be gentler on the stomach, making it easier for athletes to get the iron they need to feel their best and perform well.

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?

Iron is really important for our bodies, especially for carrying oxygen to our muscles. For young female athletes who train a lot, it's common for them to have lower iron levels. When your iron levels are low, it can make you feel tired and affect how well you can exercise.

Currently available iron supplements can sometimes cause uncomfortable side effects like stomachaches, sickness, or constipation. This means some people stop taking them even if they need them. Researchers have been working on a new way to deliver iron to the body that they hope will be much gentler on the stomach.

This study is testing this new iron supplement. They want to find out if it can successfully boost iron levels, improve the balance of healthy bacteria in the gut (which is known as the 'gut microbiome'), and ultimately help these young athletes perform better in their sport, all without causing upsetting side effects.

Key takeaways

Tests a new, gentler iron supplement for young female athletes.
Aims to improve iron levels, gut health, and sports performance.
Specifically for girls aged 14-17 with lower iron.
Involves taking the supplement for 8 weeks and reporting symptoms.
Hopes to avoid tummy side effects common with other iron pills.

Who may be eligible?

This study is looking for young women who are between 14 and 17 years old. You should have started your periods at least a year ago. It's also important that you regularly do endurance sports, like running or swimming, for at least three hours each week.

To join, you would need to have slightly lower-than-ideal iron levels. This will be checked by the study team.

You wouldn't be able to join if you've recently taken iron supplements (more than 5mg a day), or if you've taken special gut health supplements (like prebiotics or probiotics) or antibiotics in the last three months.

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 girl aged between 14 and 17?
Have you had your periods for at least a year?
Do you do at least 3 hours of endurance exercise each week?
Have you avoided other iron supplements (>5mg/day), special gut supplements, or antibiotics in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to take a small amount (40mg) of the new iron supplement every other day for eight weeks. Before you start taking anything and after the eight weeks, the study team will check your iron levels, look at your gut health, and see how well you can exercise. This will involve some tests, including one to measure your exercise capacity (how much oxygen your body uses during exercise, called VO2max).

Every week during the eight weeks you're taking the supplement, you'll fill out a short online survey. This survey will ask you about how you're feeling, your stress levels, how well you're recovering from exercise, and if you have any tummy problems. The total time you'd be involved in the study from start to finish would be around two months.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as improving your iron levels, possibly boosting your exercise performance, and helping your gut health. Since this is a new type of iron supplement, it's hoped that any side effects, especially tummy upsets, will be less common than with other iron supplements. However, as with any study, there's always a small chance of unforeseen side effects. You are free 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 necessarily very low. The study will check this with a blood test.

What does 'gut microbiome' mean?

It refers to all the good and bad bacteria that live in your gut. They play an important role in your health and digestion.

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

The study description doesn't mention a 'dummy pill' (placebo), so it seems all participants will receive the new iron supplement.

What is 'VO2max'?

It's a measure of how much oxygen your body can use during intense exercise. It's a way to check your fitness level.

Do I have to do any extra exercise for the study?

No, you just need to continue with your regular endurance sports activities as you normally would.