Back to resultsDietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE) (MAGRITTE)
Primary Purpose
Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stress Resist® (oral dietary supplement)
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring Stressed individuals, Dietary supplement, Magnesium, fMRI
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 <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.
Sites / Locations
- CHU de Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dietary supplement group
Placebo group
Arm Description
Group 1:50 stressed subjects who will have a 28-day intake of dietary supplement. Of the 50 stressed subjects, 20 subjects will participate in the fMRI exam. Dietary supplement is composed of Mg (150 mg), Vitamin B6 (0.7 mg), Vitamin B9 (100µg), Vitamin B12 (1.25 µg), rhodiola (222mg), and green tea/L-théanine (125 mg).
Group 2 (Placebo comparator (lactose)): 50 stressed subjects who will have a 28-day intake of placebo. Of the 50 stressed subjects, 20 subjects will participate in the fMRI exam.
Outcomes
Primary Outcome Measures
Measure of stress with DASS-42
The measure of stress with stress subscale in magnesium and placebo groups will be performed in order to assess the impact of the dietary supplement on this parameter. This subscale consists of 14 questions of self-evaluation, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Measure of the impact of a dietary supplement (based on Mg, vitamins, rhodiola and L-Theanine) on stress with DASS-42 after 28 days of treatment
The measure of stress with stress subscale in magnesium and placebo groups will be performed in order to assess the impact of the dietary supplement on this parameter. This subscale consists of 14 questions of self-evaluation, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Secondary Outcome Measures
Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI
Pain intensity will be assessed by the numerical pain rating scale (NPRS): the scale ranges from 0 "no pain" to 10 "maximal tolerable pain" following different thermal stimulations (using Pathway Medoc®) applied in fMRI
Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI
Pain intensity will be assessed by the numerical pain rating scale (NPRS): the scale ranges from 0 "no pain" to 10 "maximal tolerable pain" following different thermal stimulations (using Pathway Medoc®) applied in fMRI
Impact of dietary supplement on pain matrix observed by fMRI
Integration will be measured by BOLD signal at the pain matrix (primary and secondary somatosensory cortex, insular cortex, cingulate cortex prefrontal cortex and Basal Ganglia).
Impact of dietary supplement on pain matrix observed by fMRI
Integration will be measured by BOLD signal at the pain matrix (primary and secondary somatosensory cortex, insular cortex, cingulate cortex prefrontal cortex and Basal Ganglia).
Evaluation of the analgesic effect of dietary supplement during the period of 28 days of treatment
A daily pain diary will be given to patients for the 28 days of treatment in order to score their average pain during this period. Pain intensity will be assessed by the NPRS obtained from the daily pain diary: the scale ranges from 0 "no pain" to 10 "maximal tolerable pain".
Impact of dietary supplement on stress by DASS-42 questionnaire
Stress will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Impact of dietary supplement on stress by DASS-42 questionnaire
Stress will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Impact of dietary supplement on stress by DASS-42 questionnaire
Stress will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Impact of dietary supplement on stress by DASS-42 questionnaire
Stress will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Effect of dietary supplement on increased stress induced by visual stimulation
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" following different visual stimulation induced by different colors during the anticipatory phase in fMRI.
Effect of dietary supplement on increased stress induced by visual stimulation
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" following different visual stimulation induced by different colors during the anticipatory phase in fMRI.
Evaluation of the stress effect of dietary supplement by numerical scale during the period of 28 days of treatment
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" during the ratings framing the fMRI exam before and after taking a dietary supplement.
Evaluation of the stress effect of dietary supplement by numerical scale
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" during the ratings framing the fMRI exam before and after taking a dietary supplement.
Impact of dietary supplement on stress matrix observed by fMRI
Integration difference will be measured by bold signal at the stress matrix level (hippocampus, prefrontal cortex, amygdala and basal ganglia)
Impact of dietary supplement on stress matrix observed by fMRI
Integration difference will be measured by bold signal at the stress matrix level (hippocampus, prefrontal cortex, amygdala and basal ganglia)
Evaluation of stress level by daily diary
Stress level will be observed over 28 days of treatment from the daily diary data using a numerical stress scale: scores ranging from 0 "no stress" to 10 "maximal stress".
Evaluation of stress level by daily diary
Stress level will be observed over 28 days of treatment from the daily diary data using a numerical stress scale: scores ranging from 0 "no stress" to 10 "maximal stress".
Effect of dietary supplement on anxiety
Anxiety will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of anxiety.
Effect of dietary supplement on anxiety
Anxiety will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of anxiety.
Effect of dietary supplement on anxiety
Anxiety will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of anxiety.
Effect of dietary supplement on anxiety
Anxiety will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of anxiety.
Evaluation of the effect of dietary supplement on depression
Depression will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of depression
Evaluation of the effect of dietary supplement on depression
Depression will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of depression
Evaluation of the effect of dietary supplement on depression
Depression will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of depression
Evaluation of the effect of dietary supplement on depression
Depression will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of depression
Evaluation of the effect of the dietary supplement on quality of sleep
The Pittsburg Sleep Questionnaire Index is a self-questionnaire including 19 items. It was developed to measure the quality of sleep over the month before the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. In scoring the PSQI, seven component are evaluated from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score > 5 indicates a sleep disturbance.
Evaluation of the effect of the dietary supplement on quality of sleep
The Pittsburg Sleep Questionnaire Index is a self-questionnaire including 19 items. It was developed to measure the quality of sleep over the month before the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. In scoring the PSQI, seven component are evaluated from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score > 5 indicates a sleep disturbance.
Evaluation of the effect of the dietary supplement on quality of sleep
The Pittsburg Sleep Questionnaire Index is a self-questionnaire including 19 items. It was developed to measure the quality of sleep over the month before the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. In scoring the PSQI, seven component are evaluated from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score > 5 indicates a sleep disturbance.
Evaluation of the effect of the dietary supplement on quality of sleep
The Pittsburg Sleep Questionnaire Index is a self-questionnaire including 19 items. It was developed to measure the quality of sleep over the month before the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. In scoring the PSQI, seven component are evaluated from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score > 5 indicates a sleep disturbance.
Evaluation of the dietary supplement on catastrophism
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Evaluation of the dietary supplement on catastrophism
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Evaluation of the dietary supplement on catastrophism
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Evaluation of the dietary supplement on catastrophism
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Evaluation of salivary cortisol level
The concentration of cortisol will be determined by salivary cortisol dosage and will be performed before and after fMRI exam.
Evaluation of salivary cortisol level
The concentration of cortisol will be determined by salivary cortisol dosage and will be performed before and after fMRI exam.
Evaluation of Heart Rate Variability
Heart rate variability (HRV / HRV) is a measure of changes in heart rate that will provide an estimate of stress. It is usually calculated by analyzing time series of beat-by-beat intervals of the electrocardiogram or blood pressure plots (using Codesna®).
Evaluation of Heart Rate Variability
Heart rate variability (HRV / HRV) is a measure of changes in heart rate that will provide an estimate of stress. It is usually calculated by analyzing time series of beat-by-beat intervals of the electrocardiogram or blood pressure plots (using Codesna®).
Evaluation of Heart Rate Variability
Heart rate variability (HRV / HRV) is a measure of changes in heart rate that will provide an estimate of stress. It is usually calculated by analyzing time series of beat-by-beat intervals of the electrocardiogram or blood pressure plots (using Codesna®).
Analysis of the microbiota (stool samples)
The stool samples will assess to identify the bacterial biodiversity by a genetic sequencing analysis of bacterial DNA.
Analysis of the microbiota (stool samples)
The stool samples will assess to identify the bacterial biodiversity by a genetic sequencing analysis of bacterial DNA.
Assessment of the occurrence of adverse event
The adverse event will be reported by the patient on his daily diary during the period of treatment, over 28 days.
Assessment of analgesic consumption
Analgesic consumption will be assessed by the daily diary during the period of treatment, over 28 days
Influence on microbiota assessed by a food survey
A food survey will be performed by the daily diary during the period of treatment, over 28 days. Participant will have to report in his daily diary what he will have eaten per day (breakfast, lunch and dinner).
Full Information
NCT ID
NCT04391452
First Posted
April 21, 2020
Last Updated
March 1, 2022
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT04391452
Brief Title
Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)
Acronym
MAGRITTE
Official Title
Effect of a Dietary Supplement Based on Magnesium, Vitamins, Rhodiola and L-theanine (Stress Resist®), on Stress in Stressed Subjects: Randomized Study Versus Placebo.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
July 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 healthy subjects versus stressed healthy subjects without treatment.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Stressed individuals, Dietary supplement, Magnesium, fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Single blind
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary supplement group
Arm Type
Experimental
Arm Description
Group 1:50 stressed subjects who will have a 28-day intake of dietary supplement. Of the 50 stressed subjects, 20 subjects will participate in the fMRI exam. Dietary supplement is composed of Mg (150 mg), Vitamin B6 (0.7 mg), Vitamin B9 (100µg), Vitamin B12 (1.25 µg), rhodiola (222mg), and green tea/L-théanine (125 mg).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Group 2 (Placebo comparator (lactose)): 50 stressed subjects who will have a 28-day intake of placebo. Of the 50 stressed subjects, 20 subjects will participate in the fMRI exam.
Intervention Type
Dietary Supplement
Intervention Name(s)
Stress Resist® (oral dietary supplement)
Intervention Description
Stress Resist® (dietary supplement) is composed of Mg (150 mg), Vitamin B6 (0.7 mg), Vitamin B9 (100µg), Vitamin B12 (1.25 µg), rhodiola (222mg), and green tea/L-théanine (125 mg). Oral supplementation. All subjects in the MAGRITTE study will receive either a dietary supplement or a placebo for 28 days (morning intake). The effects on stress will be studied both with questionnaires, biological samples (blood, urine and stool), with a Heart Rate Variability test. 40 subjects (20 subjects per group) will have an fMRI exam.
Primary Outcome Measure Information:
Title
Measure of stress with DASS-42
Description
The measure of stress with stress subscale in magnesium and placebo groups will be performed in order to assess the impact of the dietary supplement on this parameter. This subscale consists of 14 questions of self-evaluation, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Time Frame
Day 0
Title
Measure of the impact of a dietary supplement (based on Mg, vitamins, rhodiola and L-Theanine) on stress with DASS-42 after 28 days of treatment
Description
The measure of stress with stress subscale in magnesium and placebo groups will be performed in order to assess the impact of the dietary supplement on this parameter. This subscale consists of 14 questions of self-evaluation, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI
Description
Pain intensity will be assessed by the numerical pain rating scale (NPRS): the scale ranges from 0 "no pain" to 10 "maximal tolerable pain" following different thermal stimulations (using Pathway Medoc®) applied in fMRI
Time Frame
Day 28
Title
Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI
Description
Pain intensity will be assessed by the numerical pain rating scale (NPRS): the scale ranges from 0 "no pain" to 10 "maximal tolerable pain" following different thermal stimulations (using Pathway Medoc®) applied in fMRI
Time Frame
Day 0
Title
Impact of dietary supplement on pain matrix observed by fMRI
Description
Integration will be measured by BOLD signal at the pain matrix (primary and secondary somatosensory cortex, insular cortex, cingulate cortex prefrontal cortex and Basal Ganglia).
Time Frame
Day 0
Title
Impact of dietary supplement on pain matrix observed by fMRI
Description
Integration will be measured by BOLD signal at the pain matrix (primary and secondary somatosensory cortex, insular cortex, cingulate cortex prefrontal cortex and Basal Ganglia).
Time Frame
Day 28
Title
Evaluation of the analgesic effect of dietary supplement during the period of 28 days of treatment
Description
A daily pain diary will be given to patients for the 28 days of treatment in order to score their average pain during this period. Pain intensity will be assessed by the NPRS obtained from the daily pain diary: the scale ranges from 0 "no pain" to 10 "maximal tolerable pain".
Time Frame
Over the period of treatment : Day 0 to Day 28
Title
Impact of dietary supplement on stress by DASS-42 questionnaire
Description
Stress will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Time Frame
Day 0
Title
Impact of dietary supplement on stress by DASS-42 questionnaire
Description
Stress will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Time Frame
Day 14
Title
Impact of dietary supplement on stress by DASS-42 questionnaire
Description
Stress will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Time Frame
Day 28
Title
Impact of dietary supplement on stress by DASS-42 questionnaire
Description
Stress will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of stress
Time Frame
Day 56
Title
Effect of dietary supplement on increased stress induced by visual stimulation
Description
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" following different visual stimulation induced by different colors during the anticipatory phase in fMRI.
Time Frame
Day 0
Title
Effect of dietary supplement on increased stress induced by visual stimulation
Description
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" following different visual stimulation induced by different colors during the anticipatory phase in fMRI.
Time Frame
Day 28
Title
Evaluation of the stress effect of dietary supplement by numerical scale during the period of 28 days of treatment
Description
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" during the ratings framing the fMRI exam before and after taking a dietary supplement.
Time Frame
Over the period of treatment: Day 0 to Day 28
Title
Evaluation of the stress effect of dietary supplement by numerical scale
Description
Stress intensity will be assessed by the numerical stress rating scale: the scale ranges from 0 "no stress" to 10 "maximal stress" during the ratings framing the fMRI exam before and after taking a dietary supplement.
Time Frame
Day 28
Title
Impact of dietary supplement on stress matrix observed by fMRI
Description
Integration difference will be measured by bold signal at the stress matrix level (hippocampus, prefrontal cortex, amygdala and basal ganglia)
Time Frame
Day 0
Title
Impact of dietary supplement on stress matrix observed by fMRI
Description
Integration difference will be measured by bold signal at the stress matrix level (hippocampus, prefrontal cortex, amygdala and basal ganglia)
Time Frame
Day 28
Title
Evaluation of stress level by daily diary
Description
Stress level will be observed over 28 days of treatment from the daily diary data using a numerical stress scale: scores ranging from 0 "no stress" to 10 "maximal stress".
Time Frame
Day 0
Title
Evaluation of stress level by daily diary
Description
Stress level will be observed over 28 days of treatment from the daily diary data using a numerical stress scale: scores ranging from 0 "no stress" to 10 "maximal stress".
Time Frame
Day 28
Title
Effect of dietary supplement on anxiety
Description
Anxiety will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of anxiety.
Time Frame
day 0
Title
Effect of dietary supplement on anxiety
Description
Anxiety will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of anxiety.
Time Frame
day 14
Title
Effect of dietary supplement on anxiety
Description
Anxiety will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of anxiety.
Time Frame
day 28
Title
Effect of dietary supplement on anxiety
Description
Anxiety will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of anxiety.
Time Frame
day 56
Title
Evaluation of the effect of dietary supplement on depression
Description
Depression will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of depression
Time Frame
day 0
Title
Evaluation of the effect of dietary supplement on depression
Description
Depression will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of depression
Time Frame
day 14
Title
Evaluation of the effect of dietary supplement on depression
Description
Depression will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of depression
Time Frame
day 28
Title
Evaluation of the effect of dietary supplement on depression
Description
Depression will be measured by DASS-42 questionnaire in dietary supplement and placebo groups. This subscale consists of 14 questions of self-evaluation Depression Anxiety Stress Scale-42, each of them emphasizing a negative emotional symptom, these feelings of uselessness and hopelessness. Each element is evaluated from zero to three, zero being "not present" and three being "very frequently". It assesses mental health by measuring the severity of depression
Time Frame
day 56
Title
Evaluation of the effect of the dietary supplement on quality of sleep
Description
The Pittsburg Sleep Questionnaire Index is a self-questionnaire including 19 items. It was developed to measure the quality of sleep over the month before the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. In scoring the PSQI, seven component are evaluated from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score > 5 indicates a sleep disturbance.
Time Frame
day 0
Title
Evaluation of the effect of the dietary supplement on quality of sleep
Description
The Pittsburg Sleep Questionnaire Index is a self-questionnaire including 19 items. It was developed to measure the quality of sleep over the month before the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. In scoring the PSQI, seven component are evaluated from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score > 5 indicates a sleep disturbance.
Time Frame
day 14
Title
Evaluation of the effect of the dietary supplement on quality of sleep
Description
The Pittsburg Sleep Questionnaire Index is a self-questionnaire including 19 items. It was developed to measure the quality of sleep over the month before the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. In scoring the PSQI, seven component are evaluated from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score > 5 indicates a sleep disturbance.
Time Frame
day 28
Title
Evaluation of the effect of the dietary supplement on quality of sleep
Description
The Pittsburg Sleep Questionnaire Index is a self-questionnaire including 19 items. It was developed to measure the quality of sleep over the month before the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. In scoring the PSQI, seven component are evaluated from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score > 5 indicates a sleep disturbance.
Time Frame
day 56
Title
Evaluation of the dietary supplement on catastrophism
Description
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Time Frame
day 0
Title
Evaluation of the dietary supplement on catastrophism
Description
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Time Frame
day 14
Title
Evaluation of the dietary supplement on catastrophism
Description
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Time Frame
day 28
Title
Evaluation of the dietary supplement on catastrophism
Description
Pain Catastrophizing Scale (PCS) is a questionnaire in which the patient is asked to describe the kind of thought and emotions they feel during pain. This questionnaire consists of 13 items describing different thoughts or emotions that may be associated with the pain. The patient will have to indicate how much he has these thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question.
Time Frame
day 56
Title
Evaluation of blood Magnesium (Mg) level
Description
The intracellular magnesium concentrations will be determined by the blood samples taken
Time Frame
day 0
Title
Evaluation of blood Magnesium (Mg) level
Description
The intracellular magnesium concentrations will be determined by the blood samples taken
Time Frame
day 14
Title
Evaluation of blood Magnesium (Mg) level
Description
The intracellular magnesium concentrations will be determined by the blood samples taken
Time Frame
day 28
Title
Evaluation of blood Magnesium (Mg) level
Description
The intracellular magnesium concentrations will be determined by the blood samples taken
Time Frame
day 56
Title
Evaluation of erythrocyte Mg level
Description
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Time Frame
day 0
Title
Evaluation of erythrocyte Mg level
Description
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Time Frame
day 14
Title
Evaluation of erythrocyte Mg level
Description
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Time Frame
day 28
Title
Evaluation of erythrocyte Mg level
Description
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Time Frame
day 56
Title
Evaluation of urinary Mg level
Description
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Time Frame
day 0
Title
Evaluation of urinary Mg level
Description
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Time Frame
day 14
Title
Evaluation of urinary Mg level
Description
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Time Frame
day 28
Title
Evaluation of urinary Mg level
Description
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Time Frame
day 56
Title
Evaluation of salivary cortisol level
Description
The concentration of cortisol will be determined by salivary cortisol dosage and will be performed before and after fMRI exam.
Time Frame
day 0
Title
Evaluation of salivary cortisol level
Description
The concentration of cortisol will be determined by salivary cortisol dosage and will be performed before and after fMRI exam.
Time Frame
day 28
Title
Evaluation of Heart Rate Variability
Description
Heart rate variability (HRV / HRV) is a measure of changes in heart rate that will provide an estimate of stress. It is usually calculated by analyzing time series of beat-by-beat intervals of the electrocardiogram or blood pressure plots (using Codesna®).
Time Frame
day 0
Title
Evaluation of Heart Rate Variability
Description
Heart rate variability (HRV / HRV) is a measure of changes in heart rate that will provide an estimate of stress. It is usually calculated by analyzing time series of beat-by-beat intervals of the electrocardiogram or blood pressure plots (using Codesna®).
Time Frame
day 14
Title
Evaluation of Heart Rate Variability
Description
Heart rate variability (HRV / HRV) is a measure of changes in heart rate that will provide an estimate of stress. It is usually calculated by analyzing time series of beat-by-beat intervals of the electrocardiogram or blood pressure plots (using Codesna®).
Time Frame
day 28
Title
Analysis of the microbiota (stool samples)
Description
The stool samples will assess to identify the bacterial biodiversity by a genetic sequencing analysis of bacterial DNA.
Time Frame
day 0
Title
Analysis of the microbiota (stool samples)
Description
The stool samples will assess to identify the bacterial biodiversity by a genetic sequencing analysis of bacterial DNA.
Time Frame
day 28
Title
Assessment of the occurrence of adverse event
Description
The adverse event will be reported by the patient on his daily diary during the period of treatment, over 28 days.
Time Frame
day 28
Title
Assessment of analgesic consumption
Description
Analgesic consumption will be assessed by the daily diary during the period of treatment, over 28 days
Time Frame
Day 28
Title
Influence on microbiota assessed by a food survey
Description
A food survey will be performed by the daily diary during the period of treatment, over 28 days. Participant will have to report in his daily diary what he will have eaten per day (breakfast, lunch and dinner).
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 <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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle Pickering
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)
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