The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels
10. juni 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
152
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Colin Gardner, PhD
- Telefonnummer: 678-387-7924
- E-post: colin@qualialife.com
Studer Kontakt Backup
- Navn: Abhimanyu Ardagh
- Telefonnummer: 530-263-4469
- E-post: abhi@qualialife.com
Studiesteder
-
-
California
-
Carlsbad, California, Forente stater, 92008
- Qualia Life Sciences
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 komparator: 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.
|
|
Eksperimentell: 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 komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in blood Vitamin C levels in the suboptimal stratum
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in blood Vitamin C levels in the entire cohort
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Experience Questionnaire
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: William Scuba, Qualia Life Sciences
- Hovedetterforsker: Colin Gardner, PhD, Qualia Life Sciences
- Hovedetterforsker: Sarah Blomquist, PhD, Qualia Life Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. november 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
10. juni 2026
Først innsendt som oppfylte QC-kriteriene
10. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- QLS-023
Plan for individuelle deltakerdata (IPD)
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NEI
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