ARE YOU EXPERIENCING LOW ENERGY/ FATIGUE?

Volunteers are needed to examine the effects of iron supplementation in women aged 18 to 50 years with fatigue and low iron levels.

This is a registered clinical trial with the Australian and New Zealand Clinical Trials Registry

Link to Clinical Trial Registry

click here to play a video about the study

about this study

This study is only available for people able to travel to our office in Duncraig, WA 6023

Research suggests that approximately 20% of adults experience problems with fatigue, with a higher prevalence among women than among men. Although there are many causes of fatigue, iron deficiency may be a contributing factor, with up to 41% of Australian women having low iron stores.

The primary aim of this study is to investigate the anti-fatigue effects of iron supplementation. Two forms of iron supplements will be investigated in this study: microencapsulated iron pyrophosphate (MIP) and ferrous bisglycinate (FB). We will examine the effects of these iron supplements on fatigue (primary objective), blood iron levels, cognitive performance, mood, brain fog, and general well-being. Furthermore, we will investigate how well these iron forms are tolerated.

If you are a female aged 18-50 years experiencing fatigue and believe you may have low iron levels (which we will confirm through a blood test), we invite you to participate in this randomised, controlled study. 

PLEASE NOTE: Travel to our office in Duncraig is required on THREE occasions

what does participating in this study involve?

Eligible participants will be RANDOMLY allocated into ONE of TWO treatment conditions:

  1. Daily intake of capsules containing microencapsulated iron pyrophosphate (MIP), or
  2. Daily intake of capsules containing ferrous bisglycinate (FB), or
  3. Daily intake of placebo (fake) capsules 

This 4-week study consists of the following:

  1. Participate in a 10-minute phone interview to discuss the study and assess your eligibility to participate.
  2. Have a blood sample collected from your nearest Western Diagnostics Pathology clinic on three occasions (baseline, week 4 and week 12), where your blood iron levels will be measured.
  3. Visit our office (located in Duncraig, Western Australia) on 3 occasions (baseline, week 4 and week 12). During these in-person visits (approx. 30 to 80 minutes), you will complete a questionnaire, complete a cognitive/ memory assessment, and have your weight, height and blood pressure measured.
  4. Take 1 capsule once daily for 12 weeks
  5. Complete an online questionnaire at week 8, which takes 10 to 15 minutes

You can download the full STUDY INFORMATION SHEET by clicking the button on this webpage

Do I get paid to participate in this study?

1. To compensate you for your time and travel involved in this study, you will receive a $30 gift voucher on visits 1 and 2, and a $100 gift voucher on visit 3.

2. You will undergo a bioimpedance measurement at each visit. This measures your body fat,  muscle mass, metabolic age, etc. At the end of the study, we can provide you with a report of your measurements (normally valued at $80)

3. Participants assigned to the placebo group will receive a free 12-week supply of iron supplements upon completion of this study.

what is the criteria for participating in this study?

To be INCLUDED in the study, the following inclusion criteria must be met:

  1. You are a menstruating woman
  2. You are aged 18 to 50 years
  3. Your blood ferritin levels are below the established cut-off
  4. You have self-reported fatigue/ low energy
  5. You are a non-smoker
  6. You have a BMI between 18 and 35 kg/m2
  7. You understand and are willing and able to comply with all study procedures
  8. You are willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

If any of the exclusion criteria below are met, the applicant will not be suitable for participation in this study:

  1. Your blood haemoglobin levels are below the established cut-off (indicating anaemia)
  2. You are suffering from a recently diagnosed or uncontrolled medical condition including but not limited to: severe menstrual problems including heavy bleeding or lengthy periods; unmanaged gastrointestinal disease; history of gastric surgery; cardiovascular disease; cancer/malignancy; liver disease; iron overload condition (e.g., hemochromatosis, hemosiderosis, hemoglobinopathies); stomach ulcers; diabetes; hyper/hypotension, gallbladder disease/gallstones/biliary disease, autoimmune disease, or endocrine disease.
  3. You are planning to provide blood donation during the study period
  4. You have been diagnosed with a severe psychiatric disorder (other than mild-to-moderate depression or anxiety) or neurological disease, including but not limited to Parkinson’s disease, Alzheimer’s disease, and uncontrolled epilepsy.
  5. You regularly take medications, including but not limited to proton pump inhibitors, antacids, histamine-2 receptor antagonists, nonsteroidal anti-inflammatory drugs, and antibiotics.
  6. You have changed medication in the last 3 months or have an expectation to change during the study duration
  7. You are taking iron supplements or vitamins, herbal, or other nutritional supplements reasonably expected to influence study outcomes.
  8. You have a current or 12-month history of regular illicit drug use
  9. You have an alcohol intake greater than 14 standard drinks per week
  10. You are pregnant, breastfeeding, or intend to fall pregnant in the next 3 months
  11. You plan to make major lifestyle or dietary changes, or have a planned surgery during the study period

has this study received ethics approval?

This study has been approved by the National Institute of Integrative Medicine (NIIM) Ethics Committee (Reference number: 0161E_2025)

how can i apply for this study?

If you are interested in participating in this study, please click on the button "Complete the Study Application Form" located on this webpage. This questionnaire will take aproximately 10 minutes to complete and helps us assess your eligibility to participate in this study.

Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately

can i speak to a researcher to get more information?

If you would like to speak to a researcher to get more information about this study, you can call us on 08 9448 7376

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