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

2026年6月10日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

152

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • California
      • Carlsbad、California、美国、92008
        • Qualia Life Sciences

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
膳食补充剂：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.
安慰剂比较：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.
其他：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.
实验性的：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.
膳食补充剂：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.
安慰剂比较：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.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in blood Vitamin C levels in the suboptimal stratum
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in blood Vitamin C levels in the entire cohort
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Overall Experience Questionnaire
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Qualia Life Sciences

调查人员

  • 首席研究员：William Scuba、Qualia Life Sciences
  • 首席研究员：Colin Gardner, PhD、Qualia Life Sciences
  • 首席研究员：Sarah Blomquist, PhD、Qualia Life Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • QLS-023

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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