Magnesium Deficiency, Stress, Psychological
Conditions
Keywords
magnesium deficiency, stress psycological, sleep duration and quality, mineral water rich in magnesium
Brief summary
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).
Detailed description
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.
Interventions
OTHERMg(+)
* 1,5 L per day during 30 days * No livestyle counseling
OTHERMg(-)
1,5 L water per day during 30 days No lifestyle counseling
Sponsors
Neptune
My Goodlife SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline score obtained at PSS | At Day 30 | Difference of score obtained at PSS self-administrated questionnaire at Day 30 and Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline score obtained at IPAQ | At Day 30 | Difference of score obtained at IPAQ self-administrated questionnaire at Day 30 and Day 0 |
| Change from baseline mean duration of sleep at Week 4 | At week 4 | Difference of the mean duration of sleep during the week before consumption of water and during the fourth week of consumption of water. |
| Change from baseline mean quality of sleep recorded at Week 4 | At week 4 | Difference of the mean quality of sleep during the week before consumption of water and during the fourth week of consumption of water. |
Countries
France
Outcome results
None listed