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| Name | Class |
|---|---|
| Seppic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extramel 10 mg - 140 UI SOD | Experimental | This arm receives daily one capsule Extramel 10 mg containing 140 UI of SOD. |
|
| Placebo - exipients only | Placebo Comparator | This arm receives daily one capsule Placebo containing excipients only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| 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). |
| 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 |
| 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. |
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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry CANTIN, MD | Principal Investigator | |
| Patrick LEPRINCE, MD | Study Chair | |
| Hubert TAUPE, PharmD | ISOCLIN | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24949549 | Derived | 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. |
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|
| Placebo - Excipient only | Dietary Supplement |
|
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). |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D005221 | Fatigue |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C545282 | Extramel |
| D013482 | Superoxide Dismutase |
| ID | Term |
|---|---|
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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