Clinical Trial: Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: My Goodlife SAS

Current Primary Outcome: 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


Original Primary Outcome: Difference of score obtained at PSS at D30 and D0 [ Time Frame: D0 and D30 ]

Difference of score obtained at PSS self-administrated questionnaire at D30 and D0


Current Secondary Outcome:

  • 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
  • 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.
  • 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.


Original Secondary Outcome:

  • Difference of score obtained at IPAQ at D30 and D0 [ Time Frame: D0 and D30 ]
    Difference of score obtained at IPAQ self-administrated questionnaire at D30 and D0
  • Difference of the mean duration of sleep at W0 and W4 [ Time Frame: W0 and W4 ]
    Difference of the mean duration of sleep during the week before consumption of water (W0) and during the fourth week (W4) of consumption of water.
  • Difference of mean quality of sleep recorded at W0 and W4 [ Time Frame: W0 and W4 ]
    Difference of the mean quality of sleep during the week before consumption of water (W0) and during the fourth week (W4) of consumption of water.


Information By: My Goodlife SAS

Dates:
Date Received: March 21, 2016
Date Started: July 2016
Date Completion: June 2017
Last Updated: August 1, 2016
Last Verified: August 2016