Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- F0 voice frequency
研究概览
简要总结
Preliminary data obtained by the company Pronutri, which produces food supplements based on trace metals, suggests that food supplements containing trace metal compounds could act by reducing stress, which could result in effects on various physiological parameters.
Trace elements are pure minerals essential to the functioning of our body, present in very small quantities. They have a precise and fundamental role in biological and information processes: a deficiency can lead to dysfunctions, often at the origin of our daily ailments.
No scientific study has so far been carried out to measure the effects of these molecules on physiological and psychological parameters related to stress in healthy volunteers. The present study therefore aims to test the effects of these tablets containing metals and trace metals on the reduction of stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female over 18 years of age
- •Healthy (healthy volunteers) (no current treatment except contraception and no acute illness within 3 months)
- •Affiliated to the social security system
- •Signed consent
排除标准
- •Voice disorders: aphasia, dysphonia, aphonia...
- •Presence of a cardiac pacemaker
- •Person intolerant to lactose, or to any excipient present in the VX 1 product
- •Person under legal protection or unable to give consent
- •Pregnant or post-pregnant woman under 6 months or of childbearing age without effective contraception
- •Person deprived of liberty by a judicial or administrative decision or under psychiatric care
结局指标
主要结局
F0 voice frequency
时间窗: Change from baseline at 5 minutes after the intake
The vocal parameters will be evaluated using the Praat software (duration of sound in sec, average duration of pauses in sec, average vocal frequency expressed in Hz (F0), standard deviation of F0 expressed in Hz, minimum and maximum of F0, "jitter " and "shimmer"
次要结局
未报告次要终点