Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of One Month of Daily Consumption of Mineral Water Rich in Magnesium on Perceived Stress in Healthy Consumers.

Conditions
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Magnesium Deficiency, Stress, Psychological

Intervention / Treatment
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* Other: Mg(+)
* Other: Mg(-)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mineral water rich in magnesium<br>- 1,5 L per day of mineral water containing 160 mg/L of magnesium | Other: Mg(+)<br>* 1,5 L per day during 30 days No livestyle counseling<br>|
| Active Comparator: Water low in magnesium<br>- 1,5 L per day of mineral water containing 50 mg/L of magnesium | Other: Mg(-)<br>* 1,5 L water per day during 30 days No lifestyle counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline score obtained at PSS | Difference of score obtained at PSS self-administrated questionnaire at Day 30 and Day 0 | At Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline score obtained at IPAQ | Difference of score obtained at IPAQ self-administrated questionnaire at Day 30 and Day 0 | At Day 30 | 
| Change from baseline mean duration of sleep 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. | At week 4 | 
| Change from baseline mean quality of sleep recorded 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. | At week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium deficiency, stress psycological, sleep duration and quality, mineral water rich in magnesium