Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Stress, Psychological

Treatments: Dietary Supplement: Stress Resist® (oral dietary supplement)

Study type: Interventional

Funder types: Other

Identifiers

NCT04391452

RBHP 2019 PICKERING 3

2020-A00040-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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121 participants in 2 patient groups, including a placebo group

Dietary supplement group

Experimental group

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).

Treatment:

Dietary Supplement: Stress Resist® (oral dietary supplement)

Placebo group

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Stress Resist® (oral dietary supplement)