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Completed

NCT Number: NCT02719925

Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

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).

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Key information

Conditions

Magnesium Deficiency Behavior Behavioral Symptoms Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Stress, Psychological

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

My Goodlife

Paris, Île-de-France Region, 75008, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change from baseline score obtained at PSS

    Time frame: At Day 30

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

Secondary outcomes

  1. Change from baseline score obtained at IPAQ

    Time frame: At Day 30

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

  2. Change from baseline mean duration of sleep at Week 4

    Time frame: 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.

  3. Change from baseline mean quality of sleep recorded at Week 4

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

My Goodlife SAS

Industry

Collaborators

  • Neptune

Registry information

Official study title

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

Acronym: STRESSOM15

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2016
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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