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)

January 17, 2013 updated by: Bionov

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of safety
Time Frame: Global safty evaluation performed at the end of study.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bionov

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seppic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thierry CANTIN, MD
  • Study Chair: Patrick LEPRINCE, MD
  • Study Director: Hubert TAUPE, PharmD, ISOCLIN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SE-ISO-2007-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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