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This is a randomized, double-blind, placebo-controlled, parallel-group, study evaluating the effect of a Qualia Vitamin C+ formulation on Whole Blood Vitamin C levels in the blood of healthy adults aged 25 years or older. Approximately 36 participants will be randomized to one of two study arms: Qualia Vitamin C+ or placebo. Each participant will take two capsules of their assigned product once daily in the morning, with or without food, over a 28-day period. The primary outcome is the change in blood vitamin C levels, assessed via in lab blood collection at baseline and study completion. Secondary endpoints include questionnaires measuring health-related cognitive functioning and stress (PROMIS Cognitive Function - Short Form 8a and the Perceived Stress Scale-10), the Single-item Assessment of Immune Fitness, evaluation of safety and tolerability, and an Overall Experience Questionnaire (Appendices 1, 4-7). All assessments, including electronic questionnaires, are completed remotely without in-person visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualia Vitamin c+ | Active Comparator | Qualia Vitamin C+ manufactured by Qualia Life Sciences |
|
| Placebo | Placebo Comparator | Rice flour placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualia Vitamin C+ | Dietary Supplement | Qualia Vitamin C+ manufactured by Qualia Life Sciences |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess Between-group Differences in the Change in Blood Vitamin C Levels From Baseline to Day 28 | To assess between-group differences in the change in blood Vitamin C levels from baseline to Day 28 following supplementation with Qualia Vitamin C+ versus placebo. | 0-28 days |
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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 complete questionnaires, records, and diaries associated with the study.
Healthy male and female participants aged 25 years or older. Willing to go to an Ulta Labs Patient Service Center location for a Blood Vitamin C Test (baseline and Day 29) and located within a convenient distance of participating locations. [Note: The services offered by Ulta Lab Tests are available only in the United States and not to residents of the states of New Jersey, New York, and Rhode Island.] Willing to avoid starting new or stopping any existing dietary supplements throughout the study.
Exclusion criteria:
Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding 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, 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. Adults lacking capacity to consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qualia Life Sciences | Carlsbad | California | 92011 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Qualia Vitamin c+ | Qualia Vitamin C+ manufactured by Qualia Life Sciences |
| FG001 | Placebo | Rice flour placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Qualia Vitamin c+ | Qualia Vitamin C+ manufactured by Qualia Life Sciences |
| BG001 | Placebo | Rice flour placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Assess Between-group Differences in the Change in Blood Vitamin C Levels From Baseline to Day 28 | To assess between-group differences in the change in blood Vitamin C levels from baseline to Day 28 following supplementation with Qualia Vitamin C+ versus placebo. | Per protocol population: participants who completed blood vitamin C level testing at baseline and Day 28 and took study products on at least 80% of days | Posted | Mean | Standard Deviation | mg/dL | 0-28 days |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Qualia Vitamin c+ | Qualia Vitamin C+ manufactured by Qualia Life Sciences | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Qualia Life Sciences | (855) 281-2328 | science@qualialife.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2025 | Apr 9, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001206 | Ascorbic Acid Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| Placebo | Dietary Supplement | Rice flour |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
|
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo | Rice flour placebo | 0 | 17 | 0 | 17 | 0 | 17 |
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| D009750 |
| Nutritional and Metabolic Diseases |