Effect of One Month of Daily Consumption of Mineral Water Rich in Magnesium on Perceived Stress in Healthy Consumers.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- My Goodlife SAS
- Enrollment
- 256
- Locations
- 1
- Primary Endpoint
- Change from baseline score obtained at PSS
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- 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
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
Outcomes
Primary Outcomes
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
- Change from baseline score obtained at IPAQ(At Day 30)
- Change from baseline mean duration of sleep at Week 4(At week 4)
- Change from baseline mean quality of sleep recorded at Week 4(At week 4)
Investigators
Sebastien Czernichow
Co founder of MGL
My Goodlife SAS