Life StressPhase 3Ex Stress IINCT01767922
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
A Phase 3 study testing Extramel 10 mg - 140 UI SOD in people with Life Stress and Fatigue, run by Robertet SA.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Life Stress, Fatigue, Pain
- What is being tested?
- Extramel 10 mg - 140 UI SOD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
- Being tested
- Extramel 10 mg - 140 UI SOD, Placebo - Excipient only
- Keywords
- Super-Oxyd-Dismutase, SOD, melon juce, perceived stress
- Medical subject headings
- Stress, Psychological, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extramel 10 mg - 140 UI SODDietary 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 - Excipient onlyDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Extramel 10 mg - 140 UI SOD | Experimental | This arm receives daily one capsule Extramel 10 mg containing 140 UI of SOD. Receives: Dietary Supplement: Extramel 10 mg - 140 UI SOD |
| Placebo - exipients only | Placebo comparator | This arm receives daily one capsule Placebo containing excipients only. Receives: Dietary Supplement: Placebo - Excipient only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 by Prevost subjective fatigue scale and Ruffier test.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startSep 2008
- Primary completionMay 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Life StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robertet SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seppic
- Responsible party
- Sponsor
- Investigators
- Thierry CANTIN, MD, Principal investigatorPatrick LEPRINCE, MD, Study chairHubert TAUPE, PharmD, Study director, ISOCLIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767922
- Sponsor's protocol ID
- SE-ISO-2007-01
- Acronym
- Ex Stress II
- Status last verified
- Jan 2013
- First submitted
- 11 Jan 2013
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24949549
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01767922
- Acronym / sponsor ID
- Ex Stress II / SE-ISO-2007-01
- Conditions
- Life Stress, Fatigue, Pain, Quality of Life
- Keywords
- Super-Oxyd-Dismutase, SOD, melon juce, perceived stress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Robertet SAIndustry (pharma, biotech, devices)
- Collaborators
- Seppic
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extramel 10 mg - 140 UI SOD | Experimental | Dietary Supplement: Extramel 10 mg - 140 UI SODThis arm receives daily one capsule Extramel 10 mg containing 140 UI of SOD. |
| Placebo - exipients only | Placebo comparator | Dietary Supplement: Placebo - Excipient onlyThis arm receives daily one capsule Placebo containing excipients only. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extramel 10 mg - 140 UI SODSubjects 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). | Dietary supplement | Extramel 10 mg - 140 UI SOD |
| Placebo - Excipient only | Dietary supplement | Placebo - exipients only |
Primary outcome
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.
6 secondary outcomes
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 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 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 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 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 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Derived from this study: PubMed 24949549Carillon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry CANTIN, MD principal investigator
Patrick LEPRINCE, MD study chair
Hubert TAUPE, PharmD study director
ISOCLIN
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extramel 10 mg - 140 UI SOD in people with Life Stress and Fatigue, run by Robertet SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013; AzTrials last refreshed its copy on 31 Oct 2026.