Clinical trial NCT02719925: Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers
Official title: Effect of One Month of Daily Consumption of Mineral Water Rich in Magnesium on Perceived Stress in Healthy Consumers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnesium Deficiency
Stress, Psychological
Keywords: magnesium deficiency
stress psycological
sleep duration and quality
mineral water rich in magnesium
Lead sponsor: My Goodlife SAS
Sponsor class: INDUSTRY
Collaborators: name: Neptune
First posted: 2016-03-25
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline score obtained at PSS
timeFrame: At Day 30
Secondary outcomes:
measure: Change from baseline score obtained at IPAQ
timeFrame: At Day 30
measure: Change from baseline mean duration of sleep at Week 4
timeFrame: At week 4
measure: Change from baseline mean quality of sleep recorded at Week 4
timeFrame: At week 4
Other outcomes:
Locations:
city: Paris
country: France
facility: My Goodlife
state: Ile-de-France
Study officials:
affiliation: MY GOODLIFE
name: Karl AUZOU
role: STUDY_DIRECTOR
References:
citation: McCabe D, Colbeck M. The effectiveness of essential fatty acid, B vitamin, Vitamin C, magnesium and zinc supplementation for managing stress in women: a systematic review protocol. JBI Database System Rev Implement Rep. 2015 Aug 14;13(7):104-18. doi: 10.11124/jbisrir-2015-2298. No abstract available.
citation: Endoh K, Kuriki K, Kasezawa N, Tohyama K, Goda T. Interactions between psychological stress and drinking status in relation to diet among middle-aged men and women: a large-scale cross-sectional study in Japan. J Nutr Sci Vitaminol (Tokyo). 2015;61(1):64-72. doi: 10.3177/jnsv.61.64.
citation: Vanaelst B, Michels N, Huybrechts I, Clays E, Florez MR, Balcaen L, Resano M, Aramendia M, Vanhaecke F, Rivet N, Raul JS, Lanfer A, De Henauw S. Cross-sectional relationship between chronic stress and mineral concentrations in hair of elementary school girls. Biol Trace Elem Res. 2013 Jun;153(1-3):41-9. doi: 10.1007/s12011-013-9647-2. Epub 2013 Apr 2.
citation: Sartori SB, Whittle N, Hetzenauer A, Singewald N. Magnesium deficiency induces anxiety and HPA axis dysregulation: modulation by therapeutic drug treatment. Neuropharmacology. 2012 Jan;62(1):304-12. doi: 10.1016/j.neuropharm.2011.07.027. Epub 2011 Aug 4.
citation: Grases G, Perez-Castello JA, Sanchis P, Casero A, Perello J, Isern B, Rigo E, Grases F. Anxiety and stress among science students. Study of calcium and magnesium alterations. Magnes Res. 2006 Jun;19(2):102-6.