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

NCT01767922 | Completed Phase 3

• 1 other identifier: SE-ISO-2007-01
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Life Stress; Fatigue; Pain; Quality of Life

Keywords

Super-Oxyd-Dismutase; SOD; melon juce; perceived stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 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 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 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 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).

Other Outcomes (1)

• Evaluation of safety

  Global safty evaluation performed at the end of study.

Study Arms (2)

Extramel 10 mg - 140 UI SOD

EXPERIMENTAL

This arm receives daily one capsule Extramel 10 mg containing 140 UI of SOD.

Dietary Supplement: Extramel 10 mg - 140 UI SOD

Placebo - exipients only

PLACEBO COMPARATOR

This arm receives daily one capsule Placebo containing excipients only.

Dietary Supplement: Placebo - Excipient only

Interventions

Extramel 10 mg - 140 UI SOD DIETARY_SUPPLEMENT

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).

Extramel 10 mg - 140 UI SOD

Placebo - Excipient only DIETARY_SUPPLEMENT

Placebo - exipients only

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Bionov: lead
• Seppic: collaborator

Related Publications (1)

• 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.

  PMID: 24949549 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Fatigue; Pain

Interventions

Extramel; Superoxide Dismutase

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Oxidoreductases; Enzymes; Enzymes and Coenzymes

Study Officials

• Thierry CANTIN, MD

  PRINCIPAL INVESTIGATOR

• Patrick LEPRINCE, MD

  STUDY CHAIR

• Hubert TAUPE, PharmD

  ISOCLIN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 15, 2013
• Study Start: September 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 18, 2013

Record last verified: 2013-01