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

NCT07652346 | Not Yet Recruiting

• 1 other identifier: QLS-023
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Suboptimal Vitamin C Levels; Adequate Vitamin C Levels

Keywords

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

Outcome Measures

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).

  Baseline to Day 28

Secondary Outcomes (7)

• Change in blood Vitamin C levels in the entire cohort

  Baseline to Day 28

• FACIT-Fatigue Scale

  Baseline to Day 28

• RAND-36

  Baseline to Day 28

• Single-item Assessment of Immune Fitness

  Baseline to Day 28

• Within-group change in blood Vitamin C levels

  Baseline to Day 28

Other Outcomes (2)

• Overall Experience Questionnaire

  5-7 days after final dose (Day 34-36)

• NCI Fruits and Vegetable Screener - All-Day Screener

  Baseline and Day 28

Study Arms (4)

Suboptimal Qualia Vitamin C+

EXPERIMENTAL

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.

Dietary Supplement: Qualia Vitamin C+

Suboptimal Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Adequate Qualia Vitamin C+

EXPERIMENTAL

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.

Dietary Supplement: Qualia Vitamin C+

Adequate Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

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.

Adequate Qualia Vitamin C+; Suboptimal Qualia Vitamin C+

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.

Adequate Placebo; Suboptimal Placebo

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qualia Life Sciences: lead

Study Sites (1)

Qualia Life Sciences

Carlsbad, California, 92008, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colin Gardner, PhD

  Qualia Life Sciences

  PRINCIPAL INVESTIGATOR

• William Scuba

  Qualia Life Sciences

  PRINCIPAL INVESTIGATOR

• Sarah Blomquist, PhD

  Qualia Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Gardner, PhD

CONTACT

678-387-7924; colin@qualialife.com

Abhimanyu Ardagh

CONTACT

530-263-4469; abhi@qualialife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To maintain double-blinding, a designated Qualia Life Sciences staff member independent of the research team will assign and label all study products as A or B. Both participants and study personnel will remain blinded to group assignments until study completion. Unblinding will occur only after all study data have been collected and finalized.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)