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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 that have suboptimal vitamin C blood levels (i.e., 0.4 - 0.9 mg/dL) and those with adequate vitamin C blood levels (≥0.9 mg/dL). Approximately 152 (76 in the suboptimal stratum and 76 in the adequate stratum) 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 in the suboptimal stratum, assessed via lab blood collection at baseline and study completion. Secondary endpoints include the change in blood vitamin C levels, assessed via lab blood collection at baseline and study completion in the entire group, questionnaires measuring health-related Quality of Life and fatigue (RAND-36 and the FACIT-Fatigue Scale), the Single-item Assessment of Immune Fitness, evaluation of safety and tolerability, and an Overall Experience Questionnaire. Further, a sub-group analysis of fatigued participants meeting at least mild to moderate fatigue as measured by the FACIT-Fatigue will be a secondary objective. The NCI Fruits and Vegetable Screener - All-Day Screener will also be used to assess intake at baseline and study completion. All assessments, including electronic questionnaires, are completed remotely without in-person visits.
Design: Randomized Double-Blind Placebo-Controlled Parallel 4-Armed Trial (4 arms) with 1:1:1:1 allocation, stratified by gender, age, and baseline vitamin C levels. Arms: (1) Suboptimal Qualia Vitamin C+, (2) Suboptimal Placebo, (3) Adequate Qualia Vitamin C+, and (4) Adequate Placebo. Participants will be stratified by gender and age at screening before being randomly assigned in a 1:1:1:1 ratio to one of the two study arms per stratum. Each participant will take two capsules of their assigned product daily in the morning, with or without food, for 28 consecutive days. Participants will receive a 28-day supply (56 capsules) of their assigned intervention. The active product Qualia Vitamin C+ delivers 500 mg total vitamin C per daily serving (2 capsules) and contains a blend of Vitamin C (from liposomal vitamin C, mineral ascorbates, and fruit extracts), bioflavonoids, and ferulic acid. The placebo contains inert rice powder in a vegetable/cellulose capsule. Blood vitamin C levels will be measured via blood draws through Ulta Labs, which uses licensed blood draw centers operated by Quest Diagnostics. To maintain double-blinding, a designated Qualia Life Sciences staff member independent of the research team will assign and label all study products as A or B. Both participants and study personnel will remain blinded to group assignments until study completion. The primary analysis will be ANCOVA on Day 28 serum vitamin C in the suboptimal stratum, with baseline serum vitamin C, age, and sex as covariates and treatment arm as the factor of interest. Total enrollment: 152.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suboptimal Qualia Vitamin C+ | Experimental | Participants with suboptimal vitamin C blood levels (0.4 - 0.9 mg/dL) taking two capsules of Qualia Vitamin C+ once daily in the morning, with or without food, for 28 days. 38 participants. |
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| Suboptimal Placebo | Placebo Comparator | Participants with suboptimal vitamin C blood levels (0.4 - 0.9 mg/dL) taking two capsules of placebo (inert rice powder in a vegetable/cellulose capsule) once daily in the morning, with or without food, for 28 days. 38 participants. |
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| Adequate Qualia Vitamin C+ | Experimental | Participants with adequate vitamin C blood levels (≥0.9 mg/dL) taking two capsules of Qualia Vitamin C+ once daily in the morning, with or without food, for 28 days. 38 participants. |
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| Adequate Placebo | Placebo Comparator | Participants with adequate vitamin C blood levels (≥0.9 mg/dL) taking two capsules of placebo (inert rice powder in a vegetable/cellulose capsule) once daily in the morning, with or without food, for 28 days. 38 participants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualia Vitamin C+ | Dietary Supplement | A novel multi-ingredient formulation delivering 500 mg total vitamin C per daily serving (2 capsules). It contains a blend of Vitamin C (from liposomal vitamin C, mineral ascorbates, and fruit extracts), bioflavonoids, and ferulic acid. Participants take two capsules daily in the morning, with or without food, for 28 consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood Vitamin C levels in the suboptimal stratum | To assess between-group differences in the change in blood Vitamin C levels in the suboptimal stratum from baseline to Day 28 following supplementation with Qualia Vitamin C+ versus placebo. Assessed via Ulta Labs Vitamin C Test (lab blood collection). | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood Vitamin C levels in the entire cohort | To assess between-group differences in the change in blood Vitamin C levels in the entire cohort from baseline to Day 28 following supplementation with Qualia Vitamin C+ versus placebo. | Baseline to Day 28 |
| FACIT-Fatigue Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Experience Questionnaire | Captures information that may be used for product evaluation and marketing, asked 5-7 days after the final dose of the test product. | 5-7 days after final dose (Day 34-36) |
| NCI Fruits and Vegetable Screener - All-Day Screener |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colin Gardner, PhD | Contact | 678-387-7924 | colin@qualialife.com | |
| Abhimanyu Ardagh | Contact | 530-263-4469 | abhi@qualialife.com |
| Name | Affiliation | Role |
|---|---|---|
| Colin Gardner, PhD | Qualia Life Sciences | Principal Investigator |
| William Scuba | Qualia Life Sciences | Principal Investigator |
| Sarah Blomquist, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qualia Life Sciences | Carlsbad | California | 92008 | United States |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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To maintain double-blinding, a designated Qualia Life Sciences staff member independent of the research team will assign and label all study products as A or B. Both participants and study personnel will remain blinded to group assignments until study completion. Unblinding will occur only after all study data have been collected and finalized.
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| Placebo | Other | Contains inert rice powder in a vegetable/cellulose capsule. Participants take two capsules daily in the morning, with or without food, for 28 consecutive days. |
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To assess within-group and between-group differences in the FACIT-Fatigue Scale in both the sub-optimal vitamin C stratum and the entire cohort. Final score ranges from 0 to 52, where higher scores indicate less fatigue and better quality of life. |
| Baseline to Day 28 |
| RAND-36 | To assess within-group and between-group differences in the RAND-36 (primary attention to the Vitality, General Health Perceptions, and Physical Functioning subscales) in both the sub-optimal vitamin C stratum and the entire cohort. Each domain is scored on a 0-100 scale, with higher scores indicating better health. | Baseline to Day 28 |
| Single-item Assessment of Immune Fitness | To assess within-group and between-group differences in the Single-item Assessment of Immune Fitness in both the sub-optimal vitamin C stratum and the entire cohort. A single numerical score between 0 and 10 is produced, with higher scores indicating better self-rated immune fitness. | Baseline to Day 28 |
| Within-group change in blood Vitamin C levels | To assess within-group differences in the change in blood Vitamin C levels in both the suboptimal stratum and entire cohort. | Baseline to Day 28 |
| Proportion of suboptimal group achieving status normalization | To estimate the proportion of the suboptimal group participants achieving plasma vitamin C (≥0.9 mg/dL; i.e., 'status normalization') at Week 4. | Week 4 |
| Safety and Tolerability survey | To evaluate side effect profiles using a custom Safety and Tolerability survey. | Baseline, Day 7, Day 14, Day 21, and Day 28 |
Used to assess fruit and vegetable intake at baseline and study completion, for statistical control purposes only. |
| Baseline and Day 28 |
| Qualia Life Sciences |
| Principal Investigator |