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.
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: 1. pain by the Numerical Scale and fMRI, 2. stress by the Numerical Scale and fMRI, 3. anxiety, depression and sleep with questionnaires, 4. selected biological parameters, 5. heart rate variability, 6. microbiota, 7. safety of the product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
121
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.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
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
Time frame: Day 0
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
Time frame: Day 28
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
Time frame: Day 28
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
Time frame: Day 0
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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).
Time frame: Day 0
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).
Time frame: Day 28
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".
Time frame: Over the period of treatment : Day 0 to Day 28
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
Time frame: Day 0
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
Time frame: Day 14
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
Time frame: Day 28
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
Time frame: Day 56
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.
Time frame: Day 0
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.
Time frame: Day 28
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.
Time frame: Over the period of treatment: Day 0 to Day 28
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.
Time frame: Day 28
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)
Time frame: Day 0
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)
Time frame: Day 28
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".
Time frame: Day 0
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".
Time frame: Day 28
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.
Time frame: day 0
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.
Time frame: day 14
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.
Time frame: day 28
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.
Time frame: day 56
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
Time frame: day 0
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
Time frame: day 14
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
Time frame: day 28
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
Time frame: day 56
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.
Time frame: day 0
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.
Time frame: day 14
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.
Time frame: day 28
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.
Time frame: day 56
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.
Time frame: day 0
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.
Time frame: day 14
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.
Time frame: day 28
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.
Time frame: day 56
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Time frame: day 0
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Time frame: day 14
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Time frame: day 28
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Time frame: day 56
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Time frame: day 0
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Time frame: day 14
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Time frame: day 28
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Time frame: day 56
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Time frame: day 0
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Time frame: day 14
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Time frame: day 28
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Time frame: day 56
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.
Time frame: day 0
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.
Time frame: day 28
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®).
Time frame: day 0
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®).
Time frame: day 14
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®).
Time frame: day 28
Analysis of the microbiota (stool samples)
The stool samples will assess to identify the bacterial biodiversity by a genetic sequencing analysis of bacterial DNA.
Time frame: day 0
Analysis of the microbiota (stool samples)
The stool samples will assess to identify the bacterial biodiversity by a genetic sequencing analysis of bacterial DNA.
Time frame: day 28
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.
Time frame: day 28
Assessment of analgesic consumption
Analgesic consumption will be assessed by the daily diary during the period of treatment, over 28 days
Time frame: Day 28
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).
Time frame: Day 28