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

NCT ID: NCT04391452

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-07-16

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:

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.

Conditions

Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Stress Resist® (oral dietary supplement)

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Stress Resist® (oral dietary supplement)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle Pickering

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2020-A00040-39

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2019 PICKERING 3

Identifier Type: -

Identifier Source: org_study_id