The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels
10 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
152
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Colin Gardner, PhD
- Número de teléfono: 678-387-7924
- Correo electrónico: colin@qualialife.com
Copia de seguridad de contactos de estudio
- Nombre: Abhimanyu Ardagh
- Número de teléfono: 530-263-4469
- Correo electrónico: abhi@qualialife.com
Ubicaciones de estudio
-
-
California
-
Carlsbad, California, Estados Unidos, 92008
- Qualia Life Sciences
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador de placebos: 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.
|
|
Experimental: 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.
|
|
Comparador de placebos: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in blood Vitamin C levels in the suboptimal stratum
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in blood Vitamin C levels in the entire cohort
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Experience Questionnaire
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: William Scuba, Qualia Life Sciences
- Investigador principal: Colin Gardner, PhD, Qualia Life Sciences
- Investigador principal: Sarah Blomquist, PhD, Qualia Life Sciences
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de noviembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- QLS-023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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