The Impact of Qualia Vitamin C+ on Individuals With Suboptimal and Adequate Vitamin C Levels
10 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
152
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Colin Gardner, PhD
- Número de telefone: 678-387-7924
- E-mail: colin@qualialife.com
Estude backup de contato
- Nome: Abhimanyu Ardagh
- Número de telefone: 530-263-4469
- E-mail: abhi@qualialife.com
Locais de estudo
-
-
California
-
Carlsbad, California, Estados Unidos, 92008
- Qualia Life Sciences
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Placebo: 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 Placebo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in blood Vitamin C levels in the suboptimal stratum
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in blood Vitamin C levels in the entire cohort
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Experience Questionnaire
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de novembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
10 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de junho de 2026
Primeira postagem (Real)
17 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- QLS-023
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .