- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07285109
The Impact of Qualia Vitamin C+ on Blood Vitamin C Levels
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Carlsbad, California, United States, 92011
- Qualia Life Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Rice flour placebo
|
Rice flour
|
|
Active Comparator: Qualia Vitamin c+
Qualia Vitamin C+ manufactured by Qualia Life Sciences
|
Qualia Vitamin C+ manufactured by Qualia Life Sciences
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To Assess Between-group Differences in the Change in Blood Vitamin C Levels From Baseline to Day 28
Time Frame: 0-28 days
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess within-group and between-group differences in PROMIS Cognitive Function - Short Form 8a
Time Frame: baseline to day 14 and 28
|
baseline to day 14 and 28
|
|
To assess within-group and between-group differences in Perceived Stress Scale-10 domain scores
Time Frame: baseline to day 14 and 28
|
baseline to day 14 and 28
|
|
To assess within-group and between-group differences in Single-item Assessment of Immune Fitness
Time Frame: baseline to day 14 and 28
|
baseline to day 14 and 28
|
|
To assess within-group differences in the change in blood Vitamin C levels
Time Frame: baseline to day 28
|
baseline to day 28
|
|
To evaluate side effect profiles using a custom Safety and Tolerability survey
Time Frame: baseline to day 14 and 28
|
baseline to day 14 and 28
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QLS-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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