The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorQualia Life Sciences
About this trial
This is a 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 assigned 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Qualia Vitamin C+
Dietary supplementA 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.
Placebo
Other interventionContains inert rice powder in a vegetable/cellulose capsule. Participants take two capsules daily in the morning, with or without food, for 28 consecutive days.
Treatment groups
152 Participants
are divided into 4 treatment groupsGroup A: Suboptimal Qualia Vitamin C+Experimental treatment 1 intervention
Group B: Suboptimal PlaceboPlacebo comparator 1 intervention
Group C: Adequate Qualia Vitamin C+Experimental treatment 1 intervention
Group D: Adequate PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline to Day 28Secondary outcomes
1
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.
Time frame
Baseline to Day 282
FACIT-Fatigue Scale
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.
Time frame
Baseline to Day 283
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.
Time frame
Baseline to Day 284
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.
Time frame
Baseline to Day 28Other outcomes
1
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.
Time frame
5-7 days after final dose (Day 34-36)2
NCI Fruits and Vegetable Screener - All-Day Screener
Used to assess fruit and vegetable intake at baseline and study completion, for statistical control purposes only.
Time frame
Baseline and Day 28Sponsors and contacts
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Source ClinicalTrials.gov