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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualia Iron Version A | Active Comparator | Qualia Iron version A manufactured by Qualia Life Sciences |
|
| Qualia Iron Version B | Active Comparator | Qualia Iron version B manufactured by Qualia Life Sciences |
|
| Placebo | Placebo Comparator | Rice powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualia Iron Version A | Dietary Supplement | Qualia Iron Version A manufactured by Qualia Life Sciences |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in iron status biomarkers | Between-groups changes in ferritin levels (ng/mL) will be assessed. | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in iron status biomarkers | Changes in serum iron (mcg/dL) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in iron status biomarkers | Changes in percent saturation (%) |
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Inclusion Criteria:
Ferritin 30 ng/mL (anything under 50 ng/mL is considered suboptimal, but participants with 30 ng/mL will be prioritized)
Exclusion Criteria:
Antacids Proton pump inhibitors (PPIs) Antipsychotics Antibiotics
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Scuba | Contact | 855-281-2328 | support@qualialife.com |
| Name | Affiliation | Role |
|---|---|---|
| William Scuba | Qualia Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qualia Life Sciences | Carlsbad | California | 92011 | United States |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Qualia Iron Version B | Dietary Supplement | Qualia Iron Version B manufactured by Qualia Life Sciences |
|
| Placebo | Dietary Supplement | Rice powder |
|
| From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in iron status biomarkers | Changes in total iron binding capacity (mcg/dL) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in CBC markers | Changes in hematocrit (%) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in CBC markers | Changes in hemoglobin (g/dL) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in CBC markers | Changes in red cell distribution width (%) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in CBC markers | Changes in mean corpuscular volume (fL) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in CBC markers | Changes in mean corpuscular hemoglobin (pg) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in CBC markers | Changes in mean corpuscular hemoglobin concentration (g/dL) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in CBC markers | Changes in red blood cell count (million/microliter) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in RAND 36-Item Short Form Survey (SF-36) | The RAND SF-36 captures 8 separate aspects of health-related quality of life using the same 0-to-100 scoring scale for all eight domains. Higher scores represent better health outcomes. | From 0-4 weeks, 4-8 weeks, 0-8 weeks |
| Changes in Safety and Tolerability measured by Custom Survey | Changes in safety and tolerability measures will be examined in each group using a custom survey. The survey asks about common nocibo side effects, including increasing anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, and sexual function. The scoring system goes from "not at all" to "a great deal" for each item, . The total score for each category across all participants will be calculated, and then timepoint comparisons will be made. | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in inflammatory markers | Changes in high sensitivity C-reactive protein (mg/L) | From 0-4 weeks, 4-8 weeks, and 0-8 weeks |
| Changes in iron status biomarkers | Within-groups changes in ferritin (ng/mL) will be assessed. | From 0-4 weeks, 4-8 weeks and 0-8 weeks |