Status:
COMPLETED
Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Stress, Psychological
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
The MAGRITTE monocentric study conducted at Clermont-Ferrand University Hospital is a parallel, randomized, and controlled versus placebo performed in stressed subjects. The main outcome of this stud...
Eligibility Criteria
Inclusion
- 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
- 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 \<60 ml/min,
- Receiving a treatment or dietary supplement containing Mg, pre- or probiotics, or herbal extracts (e.g. anti-stress, anti-inflammatory, analgesic) at the time of inclusion,
- Treated with antibiotics in the three months prior to inclusion,
- Having a medical and/or surgical history judged by the investigator or his or her representative that are not compatible with the trial,
- Evolutionary pathology at the time of the inclusion,
- Excessive consumption of alcohol, tobacco (up to 10 cigarettes per day), coffee, tea or drink containing caffeine (equivalent to more than 4 cups per day) or substance abuse,
- Subject who does not meet the selection criteria for their ability to discriminate against sensations resulting from nociceptive stimulation during psychometric tests,
- Subject who does not meet the selection criteria for their ability to discriminate against colours projected during the fMRI exam,
- Subject participating in another clinical trial, or in the exclusion period, or having received a total amount of compensation of more than 4,500 euros over the 12 months prior to the start of the trial,
- Woman of childbearing age not using an effective contraceptive method, pregnant woman or breastfeeding.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2021
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04391452
Start Date
July 1 2020
End Date
July 16 2021
Last Update
March 16 2022
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000