Stress, PsychologicalMAGRITTENCT04391452
Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)
A study testing Stress Resist® (oral dietary supplement) in people with Stress, Psychological, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Stress Resist® (oral dietary supplement)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 16 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- Stress Resist® (oral dietary supplement)
- Keywords
- Stressed individuals, Dietary supplement, Magnesium, fMRI
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Resist® (oral dietary supplement)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement group | Experimental | 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). Receives: Dietary Supplement: Stress Resist® (oral dietary supplement) |
| Placebo group | Placebo comparator | 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. Receives: Dietary Supplement: Stress Resist® (oral dietary supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 28
Secondary outcomes (55)
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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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".
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 56
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Measured: day 0
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Measured: day 14
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Measured: day 28
Evaluation of blood Magnesium (Mg) level
The intracellular magnesium concentrations will be determined by the blood samples taken
Measured: day 56
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Measured: day 0
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Measured: day 14
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Measured: day 28
Evaluation of erythrocyte Mg level
The erythrocyte magnesium concentrations will be determined by the blood samples taken
Measured: day 56
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Measured: day 0
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Measured: day 14
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Measured: day 28
Evaluation of urinary Mg level
The urinary concentration of magnesium will be determined by the urine collected for 24 hours.
Measured: 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.
Measured: 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.
Measured: 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®).
Measured: 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®).
Measured: 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®).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 28
Assessment of analgesic consumption
Analgesic consumption will be assessed by the daily diary during the period of treatment, over 28 days
Measured: 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).
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Jul 2020
- Primary completion1 Jun 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle Pickering, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391452
- Sponsor's protocol ID
- RBHP 2019 PICKERING 3
- Other IDs
- 2020-A00040-39
- Acronym
- MAGRITTE
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2020
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04391452
- Acronym / sponsor ID
- MAGRITTE / RBHP 2019 PICKERING 3
- Conditions
- Stress, Psychological
- Keywords
- Stressed individuals, Dietary supplement, Magnesium, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement group | Experimental | Dietary Supplement: Stress Resist® (oral dietary supplement)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). |
| Placebo group | Placebo comparator | Dietary Supplement: Stress Resist® (oral dietary supplement)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Resist® (oral dietary supplement)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. | Dietary supplement | Dietary supplement group, Placebo group |
Primary outcome
Measure of stress with DASS-42
Time frame: Day 0
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
Time frame: Day 28
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
55 secondary outcomes
Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI
Time frame: Day 28
Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI
Time frame: Day 0
Impact of dietary supplement on pain matrix observed by fMRI
Time frame: Day 0
Impact of dietary supplement on pain matrix observed by fMRI
Time frame: Day 28
Evaluation of the analgesic effect of dietary supplement during the period of 28 days of treatment
Time frame: Over the period of treatment : Day 0 to Day 28
Impact of dietary supplement on stress by DASS-42 questionnaire
Time frame: Day 0
Impact of dietary supplement on stress by DASS-42 questionnaire
Time frame: Day 14
Impact of dietary supplement on stress by DASS-42 questionnaire
Time frame: Day 28
Impact of dietary supplement on stress by DASS-42 questionnaire
Time frame: Day 56
Effect of dietary supplement on increased stress induced by visual stimulation
Time frame: Day 0
Effect of dietary supplement on increased stress induced by visual stimulation
Time frame: Day 28
Evaluation of the stress effect of dietary supplement by numerical scale during the period of 28 days of treatment
Time frame: Over the period of treatment: Day 0 to Day 28
Evaluation of the stress effect of dietary supplement by numerical scale
Time frame: Day 28
Impact of dietary supplement on stress matrix observed by fMRI
Time frame: Day 0
Impact of dietary supplement on stress matrix observed by fMRI
Time frame: Day 28
Evaluation of stress level by daily diary
Time frame: Day 0
Evaluation of stress level by daily diary
Time frame: Day 28
Effect of dietary supplement on anxiety
Time frame: day 0
Effect of dietary supplement on anxiety
Time frame: day 14
Effect of dietary supplement on anxiety
Time frame: day 28
Effect of dietary supplement on anxiety
Time frame: day 56
Evaluation of the effect of dietary supplement on depression
Time frame: day 0
Evaluation of the effect of dietary supplement on depression
Time frame: day 14
Evaluation of the effect of dietary supplement on depression
Time frame: day 28
Evaluation of the effect of dietary supplement on depression
Time frame: day 56
Evaluation of the effect of the dietary supplement on quality of sleep
Time frame: day 0
Evaluation of the effect of the dietary supplement on quality of sleep
Time frame: day 14
Evaluation of the effect of the dietary supplement on quality of sleep
Time frame: day 28
Evaluation of the effect of the dietary supplement on quality of sleep
Time frame: day 56
Evaluation of the dietary supplement on catastrophism
Time frame: day 0
Evaluation of the dietary supplement on catastrophism
Time frame: day 14
Evaluation of the dietary supplement on catastrophism
Time frame: day 28
Evaluation of the dietary supplement on catastrophism
Time frame: day 56
Evaluation of blood Magnesium (Mg) level
Time frame: day 0
Evaluation of blood Magnesium (Mg) level
Time frame: day 14
Evaluation of blood Magnesium (Mg) level
Time frame: day 28
Evaluation of blood Magnesium (Mg) level
Time frame: day 56
Evaluation of erythrocyte Mg level
Time frame: day 0
Evaluation of erythrocyte Mg level
Time frame: day 14
Evaluation of erythrocyte Mg level
Time frame: day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle Pickering principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Resist® (oral dietary supplement) in people with Stress, Psychological, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of stress with DASS-42 (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.