Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers (STRESSOM15)

My Goodlife

Status: Completed

Conditions: Magnesium Deficiency; Stress, Psychological

Treatments: Other: Mg(+); Other: Mg(-)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02719925

MGL-002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 256 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups

Mineral water rich in magnesium

Experimental group

Description:

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

Treatment:

Other: Mg(+)

Water low in magnesium

Active Comparator group

Description:

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

Treatment:

Other: Mg(-)