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

Phase 3

Completed

• Conditions: Life Stress; Fatigue; Pain; Quality of Life
• Interventions: Dietary Supplement: Extramel 10 mg - 140 UI SOD; Dietary Supplement: Placebo - Excipient only

• Registration Number: NCT01767922
• Lead Sponsor: Bionov

Brief Summary

Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact and safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived stress, physical and intellectual fatigue, pain perception, if present, and the impact on the quality of life of 70 subjects included with 60 that can be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-05
• Study Completion: 2009-09
• Status Verified: 2013-01
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-15
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extramel 10 mg - 140 UI SOD	Extramel 10 mg - 140 UI SOD	This arm receives daily one capsule Extramel 10 mg containing 140 UI of SOD.
Placebo - exipients only	Placebo - Excipient only	This arm receives daily one capsule Placebo containing excipients only.

Primary Outcome Measures

Name	Time	Method
Perceived Stress : Change from base line in Cohen PSS 14 scale at V2 and V3	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	Evaluation performed by Cohen PSS 14 scale. It should be noted that in order to be included the patient had to present a minimum score of 30 on the Cohen scale.

Secondary Outcome Measures

Name	Time	Method
Evaluation of evolution of Physical fatigue	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	Evaluation performed by Prevost subjective fatigue scale and Ruffier test.
Evaluation of evolution of Intellectual fatigue	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	Evaluation performed by Stroop test, Reverse Stroop test and 15-words Rey test.
Evaluation of evolution of pain	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	Evaluation of subjects' perceived chronic pain (if existing), was performed using a simple visual analog scale (VAS).
Evaluation of evolution of subject Quality of life	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	Evaluation of subjects' quality of life, was performed by using Personnal stress profile questionnary.