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

NCT04391452 | Completed

• 2 other identifiers: RBHP 2019 PICKERING 32020-A00040-39
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Keywords

Stressed individuals; Dietary supplement; Magnesium; fMRI

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Day 28

Secondary Outcomes (55)

• Impact of a dietary supplement on pain induced by thermal stimulation observed by fMRI

  Day 28

• 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 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

Study Arms (2)

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).

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.

Dietary Supplement: Stress Resist® (oral dietary supplement)

Interventions

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.

Dietary supplement group; Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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,
• Having a medical and/or surgical history judged by the investigator or his or her representative that are not compatible with the trial,
• 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,
• Woman of childbearing age not using an effective contraceptive method, pregnant woman or breastfeeding.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Gisèle Pickering

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 18, 2020
• Study Start: July 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 16, 2021
• Last Updated: March 16, 2022

Record last verified: 2020-04

Locations

FR (1)