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

10. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

152

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Carlsbad, California, Forenede Stater, 92008
        • Qualia Life Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: Qualia Vitamin C+
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.
Andet: Placebo
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.
Eksperimentel: 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.
Kosttilskud: Qualia Vitamin C+
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.
Andet: Placebo
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qualia Life Sciences

Efterforskere

  • Ledende efterforsker: William Scuba, Qualia Life Sciences
  • Ledende efterforsker: Colin Gardner, PhD, Qualia Life Sciences
  • Ledende efterforsker: Sarah Blomquist, PhD, Qualia Life Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • QLS-023

Plan for individuelle deltagerdata (IPD)

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