The Impact of Qualia Vitamin C+ on Blood Vitamin C Levels

NCT07285109 | Recruiting

• 1 other identifier: QLS-020
• Study Type: interventional
• Target: 36
• 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. 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.

Conditions

Vitamin C Deficiency

Outcome Measures

Primary Outcomes (1)

• To 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.

  0-28 days

Secondary Outcomes (5)

• To assess within-group and between-group differences in PROMIS Cognitive Function - Short Form 8a

  baseline to day 14 and 28

• To assess within-group and between-group differences in Perceived Stress Scale-10 domain scores

  baseline to day 14 and 28

• To assess within-group and between-group differences in Single-item Assessment of Immune Fitness

  baseline to day 14 and 28

• To assess within-group differences in the change in blood Vitamin C levels

  baseline to day 28

• To evaluate side effect profiles using a custom Safety and Tolerability survey

  baseline to day 14 and 28

Study Arms (2)

Qualia Vitamin c+

ACTIVE COMPARATOR

Qualia Vitamin C+ manufactured by Qualia Life Sciences

Dietary Supplement: Qualia Vitamin C+

Placebo

PLACEBO COMPARATOR

Rice flour placebo

Dietary Supplement: Placebo

Interventions

Qualia Vitamin C+ DIETARY_SUPPLEMENT

Qualia Vitamin C+ manufactured by Qualia Life Sciences

Qualia Vitamin c+

Placebo DIETARY_SUPPLEMENT

Rice flour

Placebo

Eligibility Criteria

• Age: 25 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 years or older. 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. \[Note: The services offered by Ulta Lab Tests are available only in the United States and not to residents of the states of New Jersey, New York, and Rhode Island.\] Willing to avoid starting new or stopping any existing dietary supplements throughout the study.

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, 92011, United States

RECRUITING

MeSH Terms

Conditions

Ascorbic Acid Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

William Scuba

CONTACT

855-281-2328; support@qualialife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 22, 2025
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)