Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

Stress, Psychological Clinical Trial

— STRESSOM15  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719925
• Other study ID #: MGL-002
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2018
• Source: My Goodlife SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Magnesium Deficiency
• Stress, Psychological

Intervention

Other:
• Mg(+)
1,5 L per day during 30 days No livestyle counseling
• Mg(-)
1,5 L water per day during 30 days No lifestyle counseling

Locations

Country	Name	City	State
France	My Goodlife	Paris	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
My Goodlife SAS	Neptune

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Grases G, Pérez-Castelló JA, Sanchis P, Casero A, Perelló 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. — View 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. Review. — View 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. — View Citation

Vanaelst B, Michels N, Huybrechts I, Clays E, Flórez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline score obtained at PSS	Difference of score obtained at PSS self-administrated questionnaire at Day 30 and Day 0	At Day 30
Secondary	Change from baseline score obtained at IPAQ	Difference of score obtained at IPAQ self-administrated questionnaire at Day 30 and Day 0	At Day 30
Secondary	Change from baseline mean duration of sleep 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.	At week 4
Secondary	Change from baseline mean quality of sleep recorded 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.	At week 4