Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Neptune | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mineral water rich in magnesium | Experimental | - 1,5 L per day of mineral water containing 160 mg/L of magnesium |
|
| Water low in magnesium | Active Comparator | - 1,5 L per day of mineral water containing 50 mg/L of magnesium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mg(+) | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline mean duration of sleep at Week 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karl AUZOU | MY GOODLIFE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| My Goodlife | Paris | ÃŽle-de-France Region | 75008 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26455850 | Background | 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. | |
| 26027597 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008275 | Magnesium Deficiency |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mg(-) |
| Other |
1,5 L water per day during 30 days No lifestyle counseling |
|
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 | 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 |
| 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. |
| 23546894 | 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. |
| 21835188 | 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. |
| 16955721 | 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. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |