Magnesium DeficiencySTRESSOM15NCT02719925
Mineral Water Rich in Magnesium and Perceived Stress in Healthy Consumers
A study testing Mg(+) and Mg(-) in people with Magnesium Deficiency and Stress, Psychological, run by My Goodlife SAS at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnesium Deficiency, Stress, Psychological
- What is being tested?
- Mg(+) and Mg(-)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Magnesium Deficiency, Stress, Psychological
- Being tested
- Mg(+), Mg(-)
- Keywords
- magnesium deficiency, stress psycological, sleep duration and quality, mineral water rich in magnesium
- Medical subject headings
- Magnesium Deficiency, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mg(+)Other
- 1,5 L per day during 30 days
- No livestyle counseling
Mg(-)Other
1,5 L water per day during 30 days No lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| Mineral water rich in magnesium | Experimental | - 1,5 L per day of mineral water containing 160 mg/L of magnesium Receives: Other: Mg(+) |
| Water low in magnesium | Active comparator | - 1,5 L per day of mineral water containing 50 mg/L of magnesium Receives: Other: Mg(-) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline score obtained at PSS
Difference of score obtained at PSS self-administrated questionnaire at Day 30 and Day 0
Measured: At Day 30
Secondary outcomes (3)
Change from baseline score obtained at IPAQ
Difference of score obtained at IPAQ self-administrated questionnaire at Day 30 and Day 0
Measured: At Day 30
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.
Measured: At week 4
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.
Measured: At week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Magnesium DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- My Goodlife SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neptune
- Responsible party
- Principal investigator, Sebastien Czernichow, My Goodlife SAS
- Investigators
- Karl AUZOU, Study director, MY GOODLIFE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719925
- Sponsor's protocol ID
- MGL-002
- Acronym
- STRESSOM15
- Status last verified
- Aug 2018
- First submitted
- 21 Mar 2016
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26455850Endoh 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.
PubMed 26027597Vanaelst 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.
PubMed 23546894Sartori 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.
PubMed 21835188Grases 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.
PubMed 16955721
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of One Month of Daily Consumption of Mineral Water Rich in Magnesium on Perceived Stress in Healthy Consumers.
- ClinicalTrials.gov ID
- NCT02719925
- Acronym / sponsor ID
- STRESSOM15 / MGL-002
- Conditions
- Magnesium Deficiency, Stress, Psychological
- Keywords
- magnesium deficiency, stress psycological, sleep duration and quality, mineral water rich in magnesium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- My Goodlife SASIndustry (pharma, biotech, devices)
- Collaborators
- Neptune
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral water rich in magnesium | Experimental | Other: Mg(+)- 1,5 L per day of mineral water containing 160 mg/L of magnesium |
| Water low in magnesium | Active comparator | Other: Mg(-)- 1,5 L per day of mineral water containing 50 mg/L of magnesium |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mg(+)* 1,5 L per day during 30 days * No livestyle counseling | Other | Mineral water rich in magnesium |
| Mg(-)1,5 L water per day during 30 days No lifestyle counseling | Other | Water low in magnesium |
Primary outcome
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
3 secondary outcomes
Change from baseline score obtained at IPAQ
Time frame: At Day 30
Change from baseline mean duration of sleep at Week 4
Time frame: At week 4
Change from baseline mean quality of sleep recorded at Week 4
Time frame: At week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Background: PubMed 26455850McCabe 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.
- Background: PubMed 26027597Endoh 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.
- Background: PubMed 23546894Vanaelst 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.
- Background: PubMed 21835188Sartori 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.
- Background: PubMed 16955721Grases 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl AUZOU study director
MY GOODLIFE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mg(+) and Mg(-) in people with Magnesium Deficiency and Stress, Psychological, run by My Goodlife SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline score obtained at PSS (time frame: At Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719925, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.