The Impact of Qualia Vitamin C+ on Blood Vitamin C Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To assess between-group differences in the change in blood Vitamin C levels from baseline to Day 28
研究概览
简要总结
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. Approximately 36 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, assessed via in lab blood collection at baseline and study completion. Secondary endpoints include questionnaires measuring health-related cognitive functioning and stress (PROMIS Cognitive Function - Short Form 8a and the Perceived Stress Scale-10), the Single-item Assessment of Immune Fitness, evaluation of safety and tolerability, and an Overall Experience Questionnaire (Appendices 1, 4-7). All assessments, including electronic questionnaires, are completed remotely without in-person visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 years or older. 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. [Note: 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.
排除标准
- •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.
研究组 & 干预措施
Qualia Vitamin c+
Qualia Vitamin C+ manufactured by Qualia Life Sciences
干预措施: Qualia Vitamin C+ (Dietary Supplement)
Placebo
Rice flour placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
To assess between-group differences in the change in blood Vitamin C levels from baseline to Day 28
时间窗: 0-28 days
To assess between-group differences in the change in blood Vitamin C levels from baseline to Day 28 following supplementation with Qualia Vitamin C+ versus placebo.
次要结局
- To assess within-group and between-group differences in Perceived Stress Scale-10 domain scores(baseline to day 14 and 28)
- To assess within-group and between-group differences in Single-item Assessment of Immune Fitness(baseline to day 14 and 28)
- To assess within-group differences in the change in blood Vitamin C levels(baseline to day 28)
- To evaluate side effect profiles using a custom Safety and Tolerability survey(baseline to day 14 and 28)
- To assess within-group and between-group differences in PROMIS Cognitive Function - Short Form 8a(baseline to day 14 and 28)