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 (Ex Stress II)

This study has been completed.
Sponsor:
Collaborator:
SEPPIC
Information provided by (Responsible Party):
Bionov
ClinicalTrials.gov Identifier:
NCT01767922
First received: January 11, 2013
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Life Stress
Fatigue
Pain
Quality of Life
Dietary Supplement: Extramel 10 mg - 140 UI SOD
Dietary Supplement: Placebo - Excipient only
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Bionov:

Primary Outcome Measures:
  • Perceived Stress : Change from base line in Cohen PSS 14 scale at V2 and V3 [ Time Frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3). ] [ Designated as safety issue: No ]
    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:
  • Evaluation of evolution of Physical fatigue [ Time Frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3). ] [ Designated as safety issue: No ]
    Evaluation performed by Prevost subjective fatigue scale and Ruffier test.

  • Evaluation of evolution of Intellectual fatigue [ Time Frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3). ] [ Designated as safety issue: No ]
    Evaluation performed by Stroop test, Reverse Stroop test and 15-words Rey test.

  • Evaluation of evolution of pain [ Time Frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3). ] [ Designated as safety issue: No ]
    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 [ Time Frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3). ] [ Designated as safety issue: No ]
    Evaluation of subjects' quality of life, was performed by using Quality of Life SF36 scale.

  • Evaluation of evolution of subject Quality of life [ Time Frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3). ] [ Designated as safety issue: No ]
    Evaluation of subjects' quality of life, was performed by using Hamilton anxiety scale.

  • Evaluation of evolution of subject Quality of life [ Time Frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3). ] [ Designated as safety issue: No ]
    Evaluation of subjects' quality of life, was performed by using Personnal stress profile questionnary.


Other Outcome Measures:
  • Evaluation of safety [ Time Frame: Global safty evaluation performed at the end of study. ] [ Designated as safety issue: Yes ]
    Assessment of the safety performed by analysis of adverse events that occurred throughout the study.


Enrollment: 61
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extramel 10 mg - 140 UI SOD
This arm receives daily one capsule Extramel 10 mg containing 140 UI of SOD.
Dietary Supplement: Extramel 10 mg - 140 UI SOD

Subjects took one capsule of Extramel® 140 IU, or its corresponding placebo, daily over 12 weeks.

Each volunteer was seen for the 3 visits:

  • visit V1, so-called inclusion visit (D0),
  • visit V2 at 28 days, tolerance of +/- 3 days, (D28) and
  • visit V3 at 84 days, tolerance of +/- 3 days, (D84).
Placebo Comparator: Placebo - exipients only
This arm receives daily one capsule Placebo containing excipients only.
Dietary Supplement: Placebo - Excipient only

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01767922

Sponsors and Collaborators
Bionov
SEPPIC
Investigators
Principal Investigator: Thierry CANTIN, MD
Study Chair: Patrick LEPRINCE, MD
Study Director: Hubert TAUPE, PharmD ISOCLIN
  More Information

No publications provided by Bionov

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bionov
ClinicalTrials.gov Identifier: NCT01767922     History of Changes
Other Study ID Numbers: SE-ISO-2007-01
Study First Received: January 11, 2013
Last Updated: January 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé

Keywords provided by Bionov:
Super-Oxyd-Dismutase
SOD
melon juce
perceived stress

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014