Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stress Psychological
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: After pre-selection (Day-14 to Day 0), participants will receive one of the two products in random order (Mg or placebo). Treatment allocation will follow a randomization plan and will be carried out by a Clinical Research Associate totally independent from the protocol. The randomization list and a copy will be edited, placed in a sealed envelope, and submitted to the Pharmacy of the University Hospital of Clermont-Ferrand and the Clinical Pharmacology Centre of Clermont-Ferrand which is the coordinating centre. For a 5% risk of bilateral species error and a 90% power, it is necessary to include 50 subjects per group to highlight such an effect size. In addition, fMRI examinations will be offered to the first 20 subjects included per group, i.e. 40 subjects, an usual and relatively consensual number for fMRI work.Masking: Single (Participant)Masking Description: Single blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 study is to demonstrate on stress the effectiveness of a dietary supplement based on magnesium (Mg), vita...
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 study is to demonstrate on stress the effectiveness of a dietary supplement based on magnesium (Mg), vitamins, rhodiola and L-Theanine, compared to placebo, in subjects with chronic stress and free from other pathologies. The secondary objectives are to evaluate the action of Mg dietary supplement on: pain by the Numerical Scale and fMRI, stress by the Numerical Scale and fMRI, anxiety, depression and sleep with questionnaires, selected biological parameters, heart rate variability, microbiota, safety of the product.
Tracking Information
- NCT #
- NCT04391452
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Gisèle Pickering University Hospital, Clermont-Ferrand
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