A Randomized, Placebo-controlled Prospective Trial for the Evaluation of Anti-oxidant, Anti-aging and Wellbeing Effects of a Novel Nutraceutical Formulation (HealthSpan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Effect of the formulation on oxidized proteins' levels
研究概览
简要总结
The study was designed as a randomized, placebo-controlled trial with follow-up at 3 months. The study is in accordance with the Declaration of Helsinki and was approved by the Institutional Bioethical Committee of the National Hellenic Research Foundation. All the study participants received informative material, filled a questionnaire regarding the self-assessment of their health status and nutritional habits, and signed their written informed consent. In total, excluding the participants that did not return for the follow-up (dropouts), 122 apparently healthy volunteers of age 29-85 were followed, with 43 of them being randomly assigned in the placebo subgroup and 79 receiving the composition of the present invention.
详细描述
The study was designed as a randomized, placebo-controlled trial with follow-up at 3 months. The study is in accordance with the Declaration of Helsinki and was approved by the Institutional Bioethical Committee of the National Hellenic Research Foundation. All the study participants received informative material, filled a questionnaire regarding the self-assessment of their health status and nutritional habits, and signed their written informed consent. Patients eligible for the inclusion criteria were randomized into two groups: the group of healthy adult volunteers that received a capsule with the active formulation and those the received the placebo (a capsule with only the carrier substance magnesium stearate) In total, excluding the participants that did not return for the follow-up (dropouts), 122 apparently healthy volunteers of age 29-85 were followed, with 43 of them being randomly assigned in the placebo subgroup and 79 receiving the composition of the present invention.
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
- 29 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •residence in the Athens metropolitan area
- •age 29-85
排除标准
- •diagnosed cancer, subjects that were under chemotherapy, therapy with biological factors and radiotherapy
- •use of nutritional supplements during the clinical trial period
- •diagnosed autoimmune diseases or other chronic diseases
- •subjects that had lived less than 50% of their life in the country that is their current residence.
结局指标
主要结局
Effect of the formulation on oxidized proteins' levels
时间窗: 3 months
Oxidative stress states can be indicative of an impaired antioxidant defense. The study focused on the assessment of oxidative stress status by the protein carbonyls' levels before and after the intervention.
次要结局
- Correlation of levels of oxidized proteins and measured 20S proteasome levels(3 months)
- Analysis of the effect of the formulation on oxidized proteins' levels adjusted for sex, age, and lifestyle habits of the sample as assessed in the study's questionnaire(3 months)