NCT07156526 · Qualia Life Sciences
Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life
What this study is about
This where neither patients nor doctors know which treatment is given parallel pilot study will evaluate the safety and effectiveness 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 treatment group$1: Qualia Iron Version 1, 2, (n=15 each) or a Placebo (n=10).
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Qualia Iron Version A
Qualia Iron Version A manufactured by Qualia Life Sciences
DIETARY_SUPPLEMENT
Qualia Iron Version B
Qualia Iron Version B manufactured by Qualia Life Sciences
DIETARY_SUPPLEMENT
Placebo
Rice powder
Primary outcome measures
Changes in iron status biomarkers
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Between-groups changes in ferritin levels (ng/mL) will be assessed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Carlsbad, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 5, 2026 · Source of record for eligibility and locations