The study will involve approximately 180 women aged over 18 years who have not yet reached menopause. Each person will participate for a period of 12 weeks.

During the 12 week study period, participants will be required to attend their local ACL pathology centre at the following 3 timepoints during the study:

1. Screening/baseline blood test at the start of the study. This test will provide your initial iron levels.
2. At 6 weeks – mid-point blood test
3. At 12 weeks – final blood test

To make the timings of these visits as convenient as possible for you, we are recruiting on a rolling basis which means that your individual start date is flexible. Your involvement in this study will be 12 weeks.

Please see below for more information. You can find the eligibility and registration form at the bottom of this page.

For this study, we are assessing the effectiveness of two different doses of a specialised iron formula for increasing iron levels.

Previous clinical studies have shown the product to have a good tolerability and safety profile, as well as promoting healthy gut microbiota.

The product will be in capsule form, and participants will be asked to take 2 capsules per day for 12 weeks.

As this study is placebo-controlled, you may or may not be allocated the active product. Once enrolled, participants will be randomly allocated to 1 of 3 groups:

A: Active group

B: Active group

C: Placebo

This means that you will have a 1 in 3 chance of being assigned the placebo (a harmless inactive substance typically used as an additive in food production). During the study period, neither you nor the study investigators will know which product you have been allocated.

Iron is an essential element used throughout the body. Due to factors including low dietary intake of iron, and blood loss through menstruation, iron deficiency is most common in pre-menopausal women.

Physical manifestations of iron deficiency include a decrease in cognitive performance and physical endurance as well as changes in immune response and mood. However, many women will remain undiagnosed without having their iron levels tested.

The most common treatment is iron supplementation containing elemental iron; however, whilst effective, there can be unwanted gastrointestinal side effects. Because of this, a novel therapy has been developed to create an iron supplement that promotes healthy gut microbiota and has increased bioavailability. It is this new supplement that is being investigated in this study.

Your involvement in the study will be 12 weeks. During this time, you will be required to take the study product each day (2 capsules a day), and complete a blood test and some questionnaires at the beginning, middle and end of the study so that we can assess the effectiveness of the study product.

3 x Blood Tests

Most of the study requirements can be completed at home; however, you will be required to attend a blood collection centre (that is local to you) during the study (beginning, week 6 and week 12) for a quick blood test.

Summary of assessments occurring at the beginning, week 6 and week 12 of the study:

• online questionnaires about your general health
• blood test for iron levels

The information we collect during the study will enable the investigators to assess the product’s effectiveness on increasing your iron levels over the 12 week study period.

You will be eligible for a $150 reimbursement to cover your time and any out-of-pocket expenses incurred in attending your blood collection visits. The payment will be made via direct deposit to your nominated bank account once all study requirements (12 weeks participation) have been met.

If you are a healthy woman, who has not yet reached menopause, and would like to participate, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.

This study is a decentralised study, which means that there are no visits to a central clinic required. At 3 timepoints during the 12 week study, you will be required to simply visit a pathology collection centre that is convenient to you. RDC will provide a referral form and a list of collection locations.

You can check the location of your closest ACL pathology collection centre HERE.

• Female over 18 years, and not yet reached menopause

• Think you may be iron deficient (feeling tired, rundown or having trouble thinking clearly) or interested in finding out your iron levels

• Not currently pregnant/lactating or trying to conceive

• Generally healthy with no uncontrolled serious illnesses

• Able to commit to the study for the 12-week period and attend 3 blood tests during that time

Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

This RDC Clinical study has been approved by Bellberry Limited human ethics committee under Approval Number: 2022-06-587. The study is also registered on the clinicaltrials.gov under Registration Number: NCT06285799. Trained Trial Co-ordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.