Skip to main content
Back to Trials
NCT07156526NARecruitingAccepts Healthy Volunteers

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

Qualia Life Sciences

Start Date

6/18/2026

Completion Date

12/31/2026

Summary

This double-blind parallel pilot study will evaluate the safety and efficacy of two Qualia Iron formulations versus placebo in approximately 40 healthy adults (aged 18+) over a 56-day period. Approximately 40 participants will be assigned to three study arms: Qualia Iron Version 1, 2, (n=15 each) or a Placebo (n=10). Each participant will take one or two capsules once daily in the morning, with or without food. The supplementation regimen is a 5 days on, 2 days off protocol, and goes for 56 days (8 weeks). The primary outcomes of this study are to assess between-group changes in iron status biomarkers. Secondary outcomes include within-group changes in iron status biomarkers, safety and tolerability as measured by a custom Safety and Tolerability survey, and RAND SF-36 quality of life scores.

Detailed Description

Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DIETARY_SUPPLEMENT

Qualia Iron Version A

DIETARY_SUPPLEMENT

Qualia Iron Version B

DIETARY_SUPPLEMENT

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Iron Deficiencies

Locations

Qualia Life Sciences

Carlsbad, California 92011

United States