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Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers (STRESSOM15)

Primary Purpose

Magnesium Deficiency, Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mg(+)
Mg(-)
Sponsored by
My Goodlife SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Magnesium Deficiency focused on measuring magnesium deficiency, stress psycological, sleep duration and quality, mineral water rich in magnesium

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • My Goodlife

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mineral water rich in magnesium

Water low in magnesium

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline score obtained at PSS
Difference of score obtained at PSS self-administrated questionnaire at Day 30 and Day 0

Secondary Outcome Measures

Change from baseline score obtained at IPAQ
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
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
Difference of the mean quality of sleep during the week before consumption of water and during the fourth week of consumption of water.

Full Information

First Posted
March 21, 2016
Last Updated
August 23, 2018
Sponsor
My Goodlife SAS
Collaborators
Neptune
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1. Study Identification

Unique Protocol Identification Number
NCT02719925
Brief Title
Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers
Acronym
STRESSOM15
Official Title
Effect of One Month of Daily Consumption of Mineral Water Rich in Magnesium on Perceived Stress in Healthy Consumers.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
My Goodlife SAS
Collaborators
Neptune

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnesium Deficiency, Stress, Psychological
Keywords
magnesium deficiency, stress psycological, sleep duration and quality, mineral water rich in magnesium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mineral water rich in magnesium
Arm Type
Experimental
Arm Description
- 1,5 L per day of mineral water containing 160 mg/L of magnesium
Arm Title
Water low in magnesium
Arm Type
Active Comparator
Arm Description
- 1,5 L per day of mineral water containing 50 mg/L of magnesium
Intervention Type
Other
Intervention Name(s)
Mg(+)
Intervention Description
1,5 L per day during 30 days No livestyle counseling
Intervention Type
Other
Intervention Name(s)
Mg(-)
Intervention Description
1,5 L water per day during 30 days No lifestyle counseling
Primary Outcome Measure Information:
Title
Change from baseline score obtained at PSS
Description
Difference of score obtained at PSS self-administrated questionnaire at Day 30 and Day 0
Time Frame
At Day 30
Secondary Outcome Measure Information:
Title
Change from baseline score obtained at IPAQ
Description
Difference of score obtained at IPAQ self-administrated questionnaire at Day 30 and Day 0
Time Frame
At Day 30
Title
Change from baseline mean duration of sleep at Week 4
Description
Difference of the mean duration of sleep during the week before consumption of water and during the fourth week of consumption of water.
Time Frame
At week 4
Title
Change from baseline mean quality of sleep recorded at Week 4
Description
Difference of the mean quality of sleep during the week before consumption of water and during the fourth week of consumption of water.
Time Frame
At week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl AUZOU
Organizational Affiliation
MY GOODLIFE
Official's Role
Study Director
Facility Information:
Facility Name
My Goodlife
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75008
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26455850
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.
Results Reference
background
PubMed Identifier
26027597
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.
Results Reference
background
PubMed Identifier
23546894
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.
Results Reference
background
PubMed Identifier
21835188
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.
Results Reference
background
PubMed Identifier
16955721
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.
Results Reference
background

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Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers

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