Effect of a Dietary Supplement Based on Magnesium, Vitamins, Rhodiola and L-theanine (Stress Resist®), on Stress in Stressed Subjects: Randomized Study Versus Placebo.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Measure of stress with DASS-42
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dietary supplement group
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).
干预措施: Stress Resist® (oral dietary supplement) (Dietary Supplement)
Placebo group
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.
干预措施: Stress Resist® (oral dietary supplement) (Dietary Supplement)
结局指标
主要结局
Measure of stress with DASS-42
时间窗: 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
时间窗: 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
次要结局
- Evaluation of the effect of the dietary supplement on quality of sleep(day 56)
- Evaluation of blood Magnesium (Mg) level(day 56)
- Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI(Day 0)
- Impact of dietary supplement on pain matrix observed by fMRI(Day 28)
- Evaluation of the analgesic effect of dietary supplement during the period of 28 days of treatment(Over the period of treatment : Day 0 to Day 28)
- Impact of dietary supplement on stress by DASS-42 questionnaire(Day 56)
- Effect of dietary supplement on increased stress induced by visual stimulation(Day 28)
- Evaluation of the stress effect of dietary supplement by numerical scale during the period of 28 days of treatment(Over the period of treatment: Day 0 to Day 28)
- Evaluation of the stress effect of dietary supplement by numerical scale(Day 28)
- Impact of dietary supplement on stress matrix observed by fMRI(Day 28)
- Evaluation of stress level by daily diary(Day 28)
- Effect of dietary supplement on anxiety(day 56)
- Evaluation of the effect of dietary supplement on depression(day 56)
- Evaluation of the dietary supplement on catastrophism(day 56)
- Evaluation of erythrocyte Mg level(day 56)
- Evaluation of urinary Mg level(day 56)
- Evaluation of salivary cortisol level(day 28)
- Evaluation of Heart Rate Variability(day 28)
- Analysis of the microbiota (stool samples)(day 28)
- Assessment of the occurrence of adverse event(day 28)
- Assessment of analgesic consumption(Day 28)
- Influence on microbiota assessed by a food survey(Day 28)
- Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI(Day 28)
- Impact of dietary supplement on pain matrix observed by fMRI(Day 0)
- Impact of dietary supplement on stress by DASS-42 questionnaire(Day 0)
- Impact of dietary supplement on stress by DASS-42 questionnaire(Day 14)
- Impact of dietary supplement on stress by DASS-42 questionnaire(Day 28)
- Effect of dietary supplement on increased stress induced by visual stimulation(Day 0)
- Impact of dietary supplement on stress matrix observed by fMRI(Day 0)
- Evaluation of stress level by daily diary(Day 0)
- Effect of dietary supplement on anxiety(day 0)
- Effect of dietary supplement on anxiety(day 14)
- Effect of dietary supplement on anxiety(day 28)
- Evaluation of the effect of dietary supplement on depression(day 0)
- Evaluation of the effect of dietary supplement on depression(day 14)
- Evaluation of the effect of dietary supplement on depression(day 28)
- Evaluation of the effect of the dietary supplement on quality of sleep(day 0)
- Evaluation of the effect of the dietary supplement on quality of sleep(day 14)
- Evaluation of the effect of the dietary supplement on quality of sleep(day 28)
- Evaluation of the dietary supplement on catastrophism(day 0)
- Evaluation of the dietary supplement on catastrophism(day 14)
- Evaluation of the dietary supplement on catastrophism(day 28)
- Evaluation of blood Magnesium (Mg) level(day 0)
- Evaluation of blood Magnesium (Mg) level(day 14)
- Evaluation of blood Magnesium (Mg) level(day 28)
- Evaluation of erythrocyte Mg level(day 0)
- Evaluation of erythrocyte Mg level(day 14)
- Evaluation of erythrocyte Mg level(day 28)
- Evaluation of urinary Mg level(day 0)
- Evaluation of urinary Mg level(day 14)
- Evaluation of urinary Mg level(day 28)
- Evaluation of salivary cortisol level(day 0)
- Evaluation of Heart Rate Variability(day 0)
- Evaluation of Heart Rate Variability(day 14)
- Analysis of the microbiota (stool samples)(day 0)