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

Qualia Life Sciences

Status: Not yet enrolling

Conditions: Iron Deficiencies

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Qualia Iron Version B; Dietary Supplement: Qualia Iron Version A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07156526

QLS-015

Details and patient eligibility

About

This randomized, 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 randomized 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 3 patient groups, including a placebo group

Qualia Iron Version A

Active Comparator group

Description:

Qualia Iron version A manufactured by Qualia Life Sciences

Treatment:

Dietary Supplement: Qualia Iron Version A

Qualia Iron Version B

Active Comparator group

Description:

Qualia Iron version B manufactured by Qualia Life Sciences

Treatment:

Dietary Supplement: Qualia Iron Version B

Placebo

Placebo Comparator group

Description:

Rice powder

Treatment:

Dietary Supplement: Placebo