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The objective of this study is to evaluate the influence of a 10 weeks SODB® supplementation in physical condition improvements of healthy subjects, in comparison to a placebo.
Beneficial experimental results have already been obtained with SODB®. That is why, the investigators expect several effects of SODB® here. Indeed, this clinical study could show that SODB® is able to improve physical conditions, and particularly at muscular and cardiac levels, by inducing a decrease in oxidative stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SODB®-physical training | Experimental | This arm receives daily two capsules of SODB® 40mg containing 560 UI of superoxide dismutase, associated with standardized physical training |
|
| Placebo-physical training | Experimental | This arm receives daily two capsules of Placebo containing excipients only, associated with standardized physical training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SODB® | Dietary Supplement | Subjects are supplemented with SODB®, daily over 10 weeks. Each volunteer was seen for the 4 visits: - visit of pre-inclusion V1, - visit V2, so-called inclusion visit, - visit V3 after 4 weeks of physical training and - visit V3 after 8 weeks of physical training |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline physical condition at 10 weeks | Evaluation performed by Ruffier test measurement | Evaluation performed at inclusion day (V2) and after 5 weeks of treatment (V3) and 10 weeks of treatment at the end of the study (V4) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of cardiac frequence | Evaluation performed by measurements of cardiac frequence during a physical test | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of maximal aerobic vitesse |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | All adverse events occured throughout the study analyzed in order to know the number of participants only with treatment-related adverse events | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Description of oxidative marker modifications in blood |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Lacan | Contact | 33(0)6 84 95 39 95 | dominique.lacan@bionov.fr | |
| Julie Carillon | Contact | 33(0)6 40 20 14 78 | jc.rech@bionov.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claire Thalamas | CIC Hospital Purpan | Principal Investigator |
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|
| Placebo | Dietary Supplement | Subjects are supplemented with Placebo, daily over 10 weeks. Each volunteer was seen for the 4 visits: - visit of pre-inclusion V1, - visit V2, so-called inclusion visit, - visit V3 after 4 weeks of physical training and - visit V3 after 8 weeks of physical training |
|
Evaluation performed by measurements of maximal aerobic vitesse during a physical test |
| Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of maximal oxygen volume | Evaluation performed by measurements of maximal oxygen volume during a physical test | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of running time | Evaluation performed by measurements of running time during a physical test | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of running distance | Evaluation performed by measurements of running distance during a physical test | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of quality of fatigue | Evaluation performed by an auto scale (Prévost) | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of quality of life | Evaluation performed by an auto scale (SF36) | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of glucose blood level | Evaluation performed by glucose measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of insulin blood level | Evaluation performed by insulin measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of cholesterol level | Evaluation performed by total and LDL-cholesterol measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of triglycerides level | Evaluation performed by triglycerides measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of inflammation | Evaluation performed by CRP (C-reactive protein) measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of ions modifications | Evaluation performed by ionogram measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of creatinemia | Evaluation performed by creatinine measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of lactate level | Evaluation performed by lactate measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of transaminases level | Evaluation performed by transaminases measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of cortisol level | Evaluation performed by cortisol measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Evaluation of testosterone level | Evaluation performed by testosterone measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
Evaluation performed by KRL (Kirial test) measurements |
| Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Description of antioxidant markers modifications in blood | Evaluation performed by antioxidant enzymes measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Description of Complete Blood Count modifications in blood | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Description of serum protein modifications in blood | Evaluation performed by Serum Protein Electrophoresis measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Description of lymphocytes nature modifications in blood | Evaluation performed by lymphocytes families percent measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |
| Description of Complement blood level modifications | Evaluation performed by C3, C4 and CH50 measurements | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) |