Clinical Pilot Study on Antioxidant Uptake and Downstream Effects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of vitamin C levels
研究概览
简要总结
A small cross-over trial on 3 different doses of liposomal vitamin C, comparing vitamin C uptake and downstream effects when 24 people consume 1, 2, and 5 grams on different test days, compared to placebo.
详细描述
A randomized, cross-over study design will be used to evaluate the effects of consumption of 4 different doses of liposomal vitamin C (0, 1, 2, and 5 grams). The study is of 5 weeks' duration, with evaluation of a different dose at each of week 1, week 3 and week 5 with a one week washout between each dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult people of either gender;
- •BMI between 18.0 and 34.9 (inclusive);
- •Willing to abstain from coffee, tea, and soft-drinks for at least one hour prior to a clinic visit;
- •Willing to abstain from alcohol for at least 12 hours prior to a clinic visit;
- •Willing to maintain a consistent habit of abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit.
排除标准
- •Cancer during past 12 months;
- •Chemotherapy during past 12 months;
- •Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
- •Previous major surgery to stomach or intestines [(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal];
- •Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
- •Food allergies related to ingredients in test product;
- •Women who are pregnant, nursing, or trying to become pregnant.
研究组 & 干预措施
Liposomal vitamin C, 1 gram
Participants will consume 1 gram on study day
干预措施: Liposomal vitamin C, 1 gram (Dietary Supplement)
Liposomal vitamin C, 2 grams
Participants will consume 2 grams on study day
干预措施: Liposomal vitamin C, 2 grams (Dietary Supplement)
Liposomal vitamin C, 5 grams
Participants will consume 5 grams on study day
干预措施: Liposomal vitamin C, 5 grams (Dietary Supplement)
Placebo
Participants will consume placebo on study day
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Evaluation of vitamin C levels
时间窗: 6 hours
HPLC (High performance liquid chromatography)
次要结局
- Evaluation of antioxidant status(6 hours)
研究者
Gitte Jensen, Ph.D.
Research Director
Natural Immune Systems Inc