NCT04912947已完成不适用
EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Erythrocytes GSH/GSSG ratio
研究概览
简要总结
The aim of the study is to verify the effectiveness of Nutraceutical IMMU·SYSTEM Dietary supplement in reducing the levels of oxidative stress and inflammation in a sample of healthy adult subjects with high baseline levels of oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian ethnicity;
- •Age between 30 and 65 years;
- •Smokers who have smoked at least 100 cigarettes in their lifetime and smoke at least 10 cigarettes a day;
- •Sportsmen who have been playing sports for at least 6 months between 4 and 8 hours per week;
- •Signature of informed consent.
排除标准
- •Systemic pathologies;
- •Active drug therapy;
- •Estrogen-progestogen therapy;
- •Pregnancy;
- •Allergies to the components of the raw material under study.
研究组 & 干预措施
Dietary supplement
Active Comparator
One cp/day of the IMMUSYSTEM food supplement for 3 months
干预措施: Immusystem (Dietary Supplement)
Placebo
Placebo Comparator
One cp/day of Placebo for 3 months
干预措施: Placebo (Other)
结局指标
主要结局
Change in Erythrocytes GSH/GSSG ratio
时间窗: Month 1
Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 1st Month
Change in Erythrocytes GSH/GSSG ratio
时间窗: Month 3
Change from Baseline reduced/oxidized glutathione ratio in erythrocytes at 3 Months
次要结局
- Change in Immune system activity(Month 1)
- Change in Immune system activity(Month 3)
研究者
FRANCESCO PUOCI
Associate Professor - DFSSN
University of Calabria
研究点 (1)
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