Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

N/ACompletedNCT02719925

My Goodlife SAS256 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

256

Conditions

Magnesium Deficiency Stress, Psychological

Interventions

Mg(+)OTHER

* 1,5 L per day during 30 days * No livestyle counseling

Mg(-)OTHER

1,5 L water per day during 30 days No lifestyle counseling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

My Goodlife

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

Change from baseline score obtained at PSS

Difference of score obtained at PSS self-administrated questionnaire at Day 30 and Day 0

Time frame: At Day 30

Secondary Outcomes

Change from baseline score obtained at IPAQ

Difference of score obtained at IPAQ self-administrated questionnaire at Day 30 and Day 0

Time frame: 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.

Time frame: 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.

Time frame: At week 4

Data from ClinicalTrials.gov

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