Clinical trial NCT01767922: 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
Official title: Multicentre, Double-blind Study Versus Placebo on the Impact and Safety of the Daily Administration of Extramel® 140 IU 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, of Which 60 That Can be Evaluated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Life Stress
Fatigue
Pain
Quality of Life
Keywords: Super-Oxyd-Dismutase
SOD
melon juce
perceived stress
Lead sponsor: Bionov
Sponsor class: INDUSTRY
Collaborators: name: Seppic
First posted: 2013-01-15
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress : Change from base line in Cohen PSS 14 scale at V2 and V3
timeFrame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Secondary outcomes:
measure: Evaluation of evolution of Physical fatigue
timeFrame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
measure: Evaluation of evolution of Intellectual fatigue
timeFrame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
measure: Evaluation of evolution of pain
timeFrame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
measure: Evaluation of evolution of subject Quality of life
timeFrame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
measure: Evaluation of evolution of subject Quality of life
timeFrame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
measure: Evaluation of evolution of subject Quality of life
timeFrame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Other outcomes:
measure: Evaluation of safety
timeFrame: Global safty evaluation performed at the end of study.
Locations:
Study officials:
name: Thierry CANTIN, MD
role: PRINCIPAL_INVESTIGATOR
name: Patrick LEPRINCE, MD
role: STUDY_CHAIR
affiliation: ISOCLIN
name: Hubert TAUPE, PharmD
role: STUDY_DIRECTOR
References:
citation: Carillon J, Notin C, Schmitt K, Simoneau G, Lacan D. Dietary supplementation with a superoxide dismutase-melon concentrate reduces stress, physical and mental fatigue in healthy people: a randomised, double-blind, placebo-controlled trial. Nutrients. 2014 Jun 19;6(6):2348-59. doi: 10.3390/nu6062348.