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)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Fatigue; Life Stress
• Intervention / Treatment: Dietary supplement: Extramel 10 mg - 140 UI SOD; Dietary supplement: Placebo - Excipient only

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress : Change from base line in Cohen PSS 14 scale at V2 and 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.	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of evolution of Physical fatigue	Evaluation performed by Prevost subjective fatigue scale and Ruffier test.	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 evolution of Intellectual fatigue	Evaluation performed by Stroop test, Reverse Stroop test and 15-words Rey test.	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 evolution of pain	Evaluation of subjects' perceived chronic pain (if existing), was performed using a simple visual analog scale (VAS).	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 evolution of subject Quality of life	Evaluation of subjects' quality of life, was performed by using Quality of Life SF36 scale.	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 evolution of subject Quality of life	Evaluation of subjects' quality of life, was performed by using Hamilton anxiety scale.	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 evolution of subject Quality of life	Evaluation of subjects' quality of life, was performed by using Personnal stress profile questionnary.	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of safety	Assessment of the safety performed by analysis of adverse events that occurred throughout the study.	Global safty evaluation performed at the end of study.

Collaborators and Investigators

• Sponsor: Bionov
• Collaborators: Seppic
• Investigators: Principal Investigator: Thierry CANTIN, MD; Study Chair: Patrick LEPRINCE, MD; Study Director: Hubert TAUPE, PharmD, ISOCLIN

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (Estimate): January 15, 2013

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 17, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: SOD; perceived stress; Super-Oxyd-Dismutase; melon juce
• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Stress, Psychological
• Other Study ID Numbers: SE-ISO-2007-01