Recruiting

Qualia Vitamin C+

Sponsor:

Qualia Life Sciences

Code:

NCT07652346

Conditions

Healthy

Suboptimal Vitamin C Levels

Adequate Vitamin C Levels

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

Qualia Vitamin C+

Placebo

Study Details

Brief summary:

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.

Conditions

Healthy

Suboptimal Vitamin C Levels

Adequate Vitamin C Levels

Study ID

NCT07652346

Start date

Aug 7, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

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 are available only in the United States and not to residents of the states of New Jersey, New York, and Rhode Island.
  • Willing to avoid starting new or stopping any existing dietary supplements throughout the study.
  • Willing to maintain a consistent diet throughout the study.

Exclusion Criteria:

  • 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.
  • Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines.
  • On immunosuppressive therapy.
  • Adults lacking capacity to consent.

Study Design

Enrollment

152 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Qualia 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.

Placebo

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Colin Gardner, PhD

678-387-7924colin@qualialife.com

Abhimanyu Ardagh

530-263-4469abhi@qualialife.com

Locations

Qualia Life Sciences

Recruiting

Carlsbad, California, United States, 92008

More Information

Sponsor

Qualia Life Sciences

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

  • Vitamin C
  • Ascorbic acid
  • Whole Blood Vitamin C
  • fatigue
  • immune function
  • Quality of Life
  • bioflavonoids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Qualia Life Sciences on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.