STRESSOM15: Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

Sponsor

My Goodlife SAS (Industry)

Overall Status

Completed

CT.gov ID

NCT02719925

Collaborator

Neptune (Industry)

256

Enrollment

Location

Arms

Duration (Months)

23.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Magnesium Deficiency Stress, Psychological	Other: Mg(+) Other: Mg(-)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mineral water rich in magnesium

- 1,5 L per day of mineral water containing 160 mg/L of magnesium

Other: Mg(+)

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

Active Comparator: Water low in magnesium

- 1,5 L per day of mineral water containing 50 mg/L of magnesium

Other: Mg(-)

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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