The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels
10 juni 2026 uppdaterad av: Qualia Life Sciences
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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Detaljerad beskrivning
Design: Randomized Double-Blind Placebo-Controlled Parallel 4-Armed Trial (4 arms) with 1:1:1:1 allocation, stratified by gender, age, and baseline vitamin C levels.
Arms: (1) Suboptimal Qualia Vitamin C+, (2) Suboptimal Placebo, (3) Adequate Qualia Vitamin C+, and (4) Adequate Placebo.
Participants will be stratified by gender and age at screening before being randomly assigned in a 1:1:1:1 ratio to one of the two study arms per stratum.
Each participant will take two capsules of their assigned product daily in the morning, with or without food, for 28 consecutive days.
Participants will receive a 28-day supply (56 capsules) of their assigned intervention.
The active product Qualia Vitamin C+ delivers 500 mg total vitamin C per daily serving (2 capsules) and contains a blend of Vitamin C (from liposomal vitamin C, mineral ascorbates, and fruit extracts), bioflavonoids, and ferulic acid.
The placebo contains inert rice powder in a vegetable/cellulose capsule.
Blood vitamin C levels will be measured via blood draws through Ulta Labs, which uses licensed blood draw centers operated by Quest Diagnostics.
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.
The primary analysis will be ANCOVA on Day 28 serum vitamin C in the suboptimal stratum, with baseline serum vitamin C, age, and sex as covariates and treatment arm as the factor of interest.
Total enrollment: 152.
Studietyp
Interventionell
Inskrivning (Beräknad)
152
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Colin Gardner, PhD
- Telefonnummer: 678-387-7924
- E-post: colin@qualialife.com
Studera Kontakt Backup
- Namn: Abhimanyu Ardagh
- Telefonnummer: 530-263-4469
- E-post: abhi@qualialife.com
Studieorter
-
-
California
-
Carlsbad, California, Förenta staterna, 92008
- Qualia Life Sciences
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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-jämförare: 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.
|
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.
|
|
Experimentell: 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.
|
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-jämförare: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in blood Vitamin C levels in the suboptimal stratum
Tidsram: Baseline to Day 28
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in blood Vitamin C levels in the entire cohort
Tidsram: Baseline to Day 28
|
To assess between-group differences in the change in blood Vitamin C levels in the entire cohort from baseline to Day 28 following supplementation with Qualia Vitamin C+ versus placebo.
|
Baseline to Day 28
|
|
FACIT-Fatigue Scale
Tidsram: Baseline to Day 28
|
To assess within-group and between-group differences in the FACIT-Fatigue Scale in both the sub-optimal vitamin C stratum and the entire cohort.
Final score ranges from 0 to 52, where higher scores indicate less fatigue and better quality of life.
|
Baseline to Day 28
|
|
RAND-36
Tidsram: Baseline to Day 28
|
To assess within-group and between-group differences in the RAND-36 (primary attention to the Vitality, General Health Perceptions, and Physical Functioning subscales) in both the sub-optimal vitamin C stratum and the entire cohort.
Each domain is scored on a 0-100 scale, with higher scores indicating better health.
|
Baseline to Day 28
|
|
Single-item Assessment of Immune Fitness
Tidsram: Baseline to Day 28
|
To assess within-group and between-group differences in the Single-item Assessment of Immune Fitness in both the sub-optimal vitamin C stratum and the entire cohort.
A single numerical score between 0 and 10 is produced, with higher scores indicating better self-rated immune fitness.
|
Baseline to Day 28
|
|
Within-group change in blood Vitamin C levels
Tidsram: Baseline to Day 28
|
To assess within-group differences in the change in blood Vitamin C levels in both the suboptimal stratum and entire cohort.
|
Baseline to Day 28
|
|
Proportion of suboptimal group achieving status normalization
Tidsram: Week 4
|
To estimate the proportion of the suboptimal group participants achieving plasma vitamin C (≥0.9 mg/dL; i.e., 'status normalization') at Week 4.
|
Week 4
|
|
Safety and Tolerability survey
Tidsram: Baseline, Day 7, Day 14, Day 21, and Day 28
|
To evaluate side effect profiles using a custom Safety and Tolerability survey.
|
Baseline, Day 7, Day 14, Day 21, and Day 28
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Experience Questionnaire
Tidsram: 5-7 days after final dose (Day 34-36)
|
Captures information that may be used for product evaluation and marketing, asked 5-7 days after the final dose of the test product.
|
5-7 days after final dose (Day 34-36)
|
|
NCI Fruits and Vegetable Screener - All-Day Screener
Tidsram: Baseline and Day 28
|
Used to assess fruit and vegetable intake at baseline and study completion, for statistical control purposes only.
|
Baseline and Day 28
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: William Scuba, Qualia Life Sciences
- Huvudutredare: Colin Gardner, PhD, Qualia Life Sciences
- Huvudutredare: Sarah Blomquist, PhD, Qualia Life Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 november 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
10 juni 2026
Först inskickad som uppfyllde QC-kriterierna
10 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- QLS-023
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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