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

NCT ID: NCT01767922

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Extramel 10 mg - 140 UI SOD

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

Group Type: EXPERIMENTAL

Extramel 10 mg - 140 UI SOD

Intervention Type: 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).

Placebo - exipients only

This arm receives daily one capsule Placebo containing excipients only.

Group Type: PLACEBO_COMPARATOR

Placebo - Excipient only

Intervention Type: DIETARY_SUPPLEMENT

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo - Excipient only

Intervention Type: DIETARY_SUPPLEMENT

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.

• 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.

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seppic

INDUSTRY

Sponsor Role: collaborator

Bionov

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry CANTIN, MD

Role: PRINCIPAL_INVESTIGATOR

Patrick LEPRINCE, MD

Role: STUDY_CHAIR

Hubert TAUPE, PharmD

Role: STUDY_DIRECTOR

ISOCLIN

References

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.

Reference Type: DERIVED

PMID: 24949549 (View on PubMed)

Other Identifiers

SE-ISO-2007-01

Identifier Type: -

Identifier Source: org_study_id