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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
36
Qualia Vitamin C+ manufactured by Qualia Life Sciences
Rice flour
Qualia Life Sciences
Carlsbad, California, United States
RECRUITINGTo 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.
Time frame: 0-28 days
To assess within-group and between-group differences in PROMIS Cognitive Function - Short Form 8a
Time frame: baseline to day 14 and 28
To assess within-group and between-group differences in Perceived Stress Scale-10 domain scores
Time frame: baseline to day 14 and 28
To assess within-group and between-group differences in Single-item Assessment of Immune Fitness
Time frame: baseline to day 14 and 28
To assess within-group differences in the change in blood Vitamin C levels
Time frame: baseline to day 28
To evaluate side effect profiles using a custom Safety and Tolerability survey
Time frame: baseline to day 14 and 28
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