The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels
Qualia Life Sciences
Summary
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.
Description
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 rece…
Eligibility
- Age range
- 25–75 years
- Sex
- All
- Healthy volunteers
- Yes
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 to 75 years old. * 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. The services offered by Ulta Lab Tests a…
Interventions
- Dietary SupplementQualia Vitamin C+
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.
- OtherPlacebo
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.
Location
- Qualia Life SciencesCarlsbad, California