Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot, non-randomized, three-arm study compares two Qualia Iron formulations with placebo in approximately 40 healthy adults aged 18 and older over 56 days. Participants take one or two capsules daily in a 5 days on/2 days off schedule, with either morning meals or none, and complete biomarkers, safety surveys, and quality-of-life assessments. Primary outcomes examine changes in iron status biomarkers between groups, while secondary outcomes assess within-group biomarker changes, safety/tolerability, and RAND SF-36 scores. Allocation is non-randomized, with selection influenced by initial ferritin and iron inadequacy metrics. The study is conducted at Qualia Life Sciences in Carlsbad, CA, with a focus on safety and tolerability alongside biomarker testing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provide voluntary, written, informed consent to participate in the study
* Agree to provide a valid cell phone number and are willing to receive communications through text
* Can read and write English
* Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
* Willing to complete questionnaires, records, and diaries associated with the study.
* If the participant responded "Yes" to ≥2 questions on the custom Iron Inadequacy Questionnaire. Preference will be given to participants with a higher score.
* If a participant has the following:

Ferritin 30 ng/mL (anything under 50 ng/mL is considered suboptimal, but participants with 30 ng/mL will be prioritized)

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
* Known food intolerances/allergy to any ingredients in the product
* Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, irritable bowel disease, cancer
* Having had a significant cardiovascular event in the past 6 months
* Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
* On immunosuppressive therapy
* Individuals who were deemed incompatible with the test protocol
* Adults lacking capacity to consent
* Individuals taking any of the following medications:

Antacids Proton pump inhibitors (PPIs) Antipsychotics Antibiotics

Where it's running

• Qualia Life Sciences
  Carlsbad, California, United States Recruiting

Study contacts

• Principal investigator: William Scuba — Qualia Life Sciences
• Study coordinator: William Scuba
• Email: support@qualialife.com
• Phone: 855-281-2328

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.