Effect of One Month of Daily Consumption of Mineral Water Rich in Magnesium on Perceived Stress in Healthy Consumers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Change from baseline score obtained at PSS
研究概览
简要总结
The goal of clinical trial is to evaluate the effect of one month of consumption of mineral water rich in magnesium or not on perceived stress, duration and quality of sleep in healthy consumers having magnesium daily intakes below the recommended dietary allowance (RDA).
详细描述
This is a single-center, double-blind, controlled, randomized, 2 parallel-groups clinical trial.
256 healthy volunteers will be recruited for clinical trial if they meet the inclusion and no inclusion criteria.
50% of volunteers (Mg+ group) will drink daily 1,5 L of mineral water rich in magnesium during 30 days
50% of volunteers (Mg- group) will drink daily 1,5 L of water low in magnesium during 30 days
Volunteers in both groups will be equipped with a wristband-connected device allowing recording of duration and quality of sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a magnesium daily intakes lower than the recommended dietary allowance (RDA)
- •a score at perceived stress scale (PPS) greater than or equal to 25
- •BMI > 18 et < 25 kg/m2
- •Describing himself as tired for reasons of stress or lack of sleep.
- •Do not take any medication likely to act on stress and sleep as anxiolytics, hypnotics, antidepressants, etc.
- •Knowing read and write French routinely,
- •Possessing an internet connection at home,
- •Possessing and knowing how to use a computer or tablet,
- •Owning a smartphone,
- •Affiliated with a social security scheme
- •Not Trust
- •Having signed the informed consent letter
排除标准
- •Pregnant or breast-feeding or planning an early pregnancy during the study
- •Severe chronic condition or type of acute disease: vascular cardio - pulmonary - renal - Hematologic - Liver - endocrine (thyroid) - allergic
- •Inability to understand information about the protocol and / or to sign the informed consent
研究组 & 干预措施
Mineral water rich in magnesium
- 1,5 L per day of mineral water containing 160 mg/L of magnesium
干预措施: Mg(+) (Other)
Water low in magnesium
- 1,5 L per day of mineral water containing 50 mg/L of magnesium
干预措施: Mg(-) (Other)
结局指标
主要结局
Change from baseline score obtained at PSS
时间窗: At Day 30
Difference of score obtained at PSS self-administrated questionnaire at Day 30 and Day 0
次要结局
- Change from baseline score obtained at IPAQ(At Day 30)
- Change from baseline mean duration of sleep at Week 4(At week 4)
- Change from baseline mean quality of sleep recorded at Week 4(At week 4)
研究者
Sebastien Czernichow
Co founder of MGL
My Goodlife SAS