Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

Not Applicable

Completed

• Conditions: Stress, Psychological; Magnesium Deficiency
• Interventions: Other: Mg(+); Other: Mg(-)

• Registration Number: NCT02719925
• Lead Sponsor: My Goodlife SAS

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.

Study Timeline

• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Study Start: 2016-07
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral water rich in magnesium	Mg(+)	- 1,5 L per day of mineral water containing 160 mg/L of magnesium
Water low in magnesium	Mg(-)	- 1,5 L per day of mineral water containing 50 mg/L of magnesium

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

My Goodlife; 🇫🇷 Paris, Ile-de-France, France