Multicentre, Double-blind Study Versus Placebo on Impact and Safety of Extramel® 140 IU on Perceived Stress, Physical and Intellectual Fatigue, Pain Perception if Present, and the Impact on the Quality of Life

Inclusion criteria

• Male or female person using an effective contraceptive method, with a negative urine pregnancy test on the inclusion visit for the women of reproductive age.
• Older than 30 years and younger than 65 years
• BMI ≤ 30
• Score greater than 30 on the Cohen perceived stress scale PSS 14.
• Score between 5 and 20 in the Hamilton anxiety scale (excluding the limits).
• Presenting an impact of stress on at least one of the following domains.

• pain domain with a score greater than 20 millimeters measured on the visual pain evaluation scale,
• physical condition domain with a score greater than 50 on the Prevost subjective fatigue scale,
• the psychical condition domain with a global score below 160 in the Stroop test and the reverse Stroop test.
• Stable professional activity since at least 1 year.
• Completely healthy on the day of inclusion, and not taking any medicinal product or dietary supplement with an anti-stress or anti-pain objective.
• Not taking any herbal tea or drink with an anti-stress or anti-pain objective.
• Accepting not to modify his/her dietary habits.
• Having given his/her free, informed and express consent.
• Capable of understanding the nature of the objectives, the consequences of the study and accepting to comply with the protocol requirements.
• Affiliated with a social security insurance or beneficiary of such an insurance system.

Exclusion criteria

• Subject presenting an acute pain or pain considered to be incapacitating by the patient him/herself or the observer physician.
• Subject currently under a chronic or acute treatment indicated for stress or anxiety, irrespective of the treatment.
• Subject currently under a chronic or acute treatment indicated for pain problems, irrespective of the treatment.
• Pregnant and/or breast-feeding women.
• Any person who does not satisfy by definition the inclusion criteria.
• Adult protected by the law.
• Any history of psychiatric disease.
• Any pathology in progress or active in the previous month.
• Any administration of a dietary supplement in progress or in the previous month.
• Any subject who within the 3 months following inclusion is likely to experience a major modification of his/her life rhythm (For example marriage, birth of a child, scheduled hospitalization, important exam, etc.) this is left to the discretion of the investigator.