The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels

Conditions

• Adequate Vitamin C Levels
• Healthy
• Suboptimal Vitamin C Levels

Eligibility Criteria

Sex

ALL

Age

25 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• 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.
• 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.

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Nov 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

152 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Suboptimal Qualia Vitamin C+
  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.
• Placebo Comparator: Suboptimal Placebo
  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.
• Experimental: Adequate Qualia Vitamin C+
  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.
• Placebo Comparator: Adequate Placebo
  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.

Primary Outcome Measure

Change in blood Vitamin C levels in the suboptimal stratum [ Time Frame: Baseline to Day 28 ]

Central Contacts

• Colin Gardner, PhD
  678-387-7924
  [email protected]
• Abhimanyu Ardagh
  530-263-4469
  [email protected]

Locations (1)

Find similar trials in Carlsbad, CA

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