Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

NCT02719925 | Completed

• 1 other identifier: MGL-002
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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).

Conditions

Magnesium Deficiency; Stress, Psychological

Keywords

magnesium deficiency; stress psycological; sleep duration and quality; mineral water rich in magnesium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Mineral water rich in magnesium

EXPERIMENTAL

\- 1,5 L per day of mineral water containing 160 mg/L of magnesium

Other: Mg(+)

Water low in magnesium

ACTIVE COMPARATOR

\- 1,5 L per day of mineral water containing 50 mg/L of magnesium

Other: Mg(-)

Interventions

Mg(-) OTHER

1,5 L water per day during 30 days No lifestyle counseling

Water low in magnesium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• My Goodlife SAS: lead
• Neptune: collaborator

Study Sites (1)

My Goodlife

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

Location

Related Publications (5)

• 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.

  PMID: 26455850 BACKGROUND

• 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.

  PMID: 26027597 BACKGROUND

• 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.

  PMID: 23546894 BACKGROUND

• 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.

  PMID: 21835188 BACKGROUND

• 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.

  PMID: 16955721 BACKGROUND

MeSH Terms

Conditions

Magnesium Deficiency; Stress, Psychological

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Karl AUZOU

  MY GOODLIFE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co founder of MGL

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 25, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)