Fatigue, Life Stress, Pain, Quality of Life
Conditions
Keywords
Super-Oxyd-Dismutase, SOD, melon juce, perceived stress
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.
Interventions
DIETARY_SUPPLEMENTExtramel 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).
DIETARY_SUPPLEMENTPlacebo - Excipient only
Sponsors
Seppic
Bionov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress : Change from base line in Cohen PSS 14 scale at V2 and V3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 performed by Prevost subjective fatigue scale and Ruffier test. |
| 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 performed by Stroop test, Reverse Stroop test and 15-words Rey test. |
| 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 subjects' perceived chronic pain (if existing), was performed using a simple visual analog scale (VAS). |
| 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 subjects' quality of life, was performed by using Quality of Life SF36 scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of safety | Global safty evaluation performed at the end of study. | Assessment of the safety performed by analysis of adverse events that occurred throughout the study. |
Outcome results
None listed