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Completed
NCT04391452
Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)
Conditions: Stress, Psychological
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 121
Sponsor: University Hospital, Clermont-Ferrand
Location: CHU de Clermont-Ferrand Clermont-Ferrand
Summary
The aim is to study the effect of a dietary supplement on stress and pain through questionnaires and follow-up of physiological parameters, and functional Magnetic Resonance Imaging (fMRI) in stressed healthy subjects versus stressed healthy subjects without treatment.
Eligibility Criteria
Inclusion Criteria:
* Male or female aged 18 to 65,
* Subject with stress (DASS-42 screening scale ≥14) and having been under stress for at least 1 month,
* Subject free of any introduction of new treatment or diet at the time inclusion,
* Subject free of any treatment in the 7 days prior to inclusion including no use of analgesic or anti-inflammatory drugs,
* Cooperation and understanding sufficient to comply with the requirements of the study,
* Acceptance to give written consent,
* Affiliation with the French Social Security,
* Registration or acceptance of registration in the national register of volunteers participating in Research.
Exclusion Criteria:
* Contraindications to the realization of MRI without injection such as claustrophobia proven, hearing aid, pacemaker wearers, wearing a brain clip,
* Contraindication to Mg administration: hypersensitivity to Mg oxide, or to one of the excipients,
* With magnesemia \> 1.07 mmol/l,
* With moderate (or more severe) kidney failure with creatinine clearance \
Source: ClinicalTrials.gov (NCT04391452). StuddyBuddy aggregates publicly available trial information.