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

August 23, 2018 updated by: Sebastien Czernichow, My Goodlife SAS

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75008
        • My Goodlife

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mineral water rich in magnesium
- 1,5 L per day of mineral water containing 160 mg/L of magnesium
Other: Mg(+)
  • 1,5 L per day during 30 days
  • No livestyle counseling
ACTIVE_COMPARATOR: Water low in magnesium
- 1,5 L per day of mineral water containing 50 mg/L of magnesium
Other: Mg(-)
1,5 L water per day during 30 days No lifestyle counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline score obtained at IPAQ
Time Frame: At Day 30
Difference of score obtained at IPAQ self-administrated questionnaire at Day 30 and Day 0
At Day 30
Change from baseline mean duration of sleep at Week 4
Time Frame: 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
Change from baseline mean quality of sleep recorded at Week 4
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

My Goodlife SAS

Collaborators

Neptune

Investigators

  • Study Director: Karl AUZOU, My Goodlife

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (ESTIMATE)

March 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGL-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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