The Impact of Qualia Gluthathione+ on Blood Glutathione Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Total Glutathione levels from baseline to Day 20
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group, triple-armed, study evaluating the effects of two distinct Qualia Glutathione+ formulations on Whole Blood Glutathione levels in the blood of healthy adults aged 45-75 years. Approximately 18 participants will be randomized to one of three study arms: Qualia Glutathione+ version 1, Qualia Glutathione+ version 2, or placebo. Each participant will take two or three capsules of their assigned product once daily in the morning, with or without food, over a 20-day period. The primary outcome is the change in blood glutathione levels, assessed via in lab blood collection at baseline and study completion. Secondary endpoints include questionnaires measuring health-related quality of life, fatigue, and cognitive functioning (PROMIS Global Health-10, PROMIS Short Form v1.0 - Fatigue 10a, PROMIS Cognitive Function - Short Form 8a), 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
- 45 Years 至 75 Years（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 not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
- •Willing to complete questionnaires, records, and diaries associated with the study.
- •Healthy male and female participants aged 45-75 years
- •Willing to go to a local blood draw location for a Whole Blood Total Glutathione measurement (baseline and Day 20)
- •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 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
- •Active Smokers
- •Diagnosed Diabetics
结局指标
主要结局
Total Glutathione levels from baseline to Day 20
时间窗: 0-20 days
To assess between-group differences in the change in blood Total Glutathione levels from baseline to Day 20 following supplementation with Qualia Glutathione version 1 versus placebo and Qualia Glutathione version 2 versus placebo
次要结局
- between-group differences in blood Total Glutathione levels(baseline to day 20)
- within-group differences in the change in blood Glutathione levels(baseline to day 20)
- Safety and Tolerability survey(baseline to days 7, 14 and 20)
- PROMIS Global Health-10(baseline to days 7, 14 and 20)
- PROMIS Short Form v1.0 - Fatigue 10a(baseline to days 7, 14 and 20)
- PROMIS Cognitive Function - Short Form 8a(baseline to days 7, 14 and 20)
- between-group differences in blood Total Glutathione levels(baseline to day 20)
- within-group differences in the change in blood Glutathione levels(baseline to day 20)
- Safety and Tolerability survey(baseline to days 7, 14 and 20)