Evaluation of SODB® (Superoxide Dismutase by Bionov®) in the Physical Condition Improvement in Healthy Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of SODB®, Associated With a Physical Training, in the Physical Condition Improvement in Healthy Subjects: Randomized Double-blind Study Versus Placebo

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: SODB®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ruffier score between 8 and 12 18.5 < Body Mass Index < 27 kg/m2 stable weight (variation < 5% over the last 3 months) stable diet over the last 3 months normal biological exam arterial pressure < 140/90 mm Hg normal ECG no contraindication for running subject having given his free, informed and express consent subject affiliated with a social security insurance or beneficiary of such an insurance system time to go to the physical training twice per week Exclusion Criteria: subject who do not understand the study > 5 cigarets per day slimming diet over the last 3 months contraindication for running or physical test subject who failed the Cooper test anormal ECG anormal biological results dyslipidemia under current statins treatment hypertension diabeta II chronic respiratory disease rheumatic disease orthopedic disease positive serology for hepatitis B, C or HIV under current corticoids treatment under current drugs (medicine or not) any allergy to utilized one of the compounds of the experimental or placebo product alcool > 36g/day consumption of drinks containing caffein, taurine, creatin, guarana, ginseng, ginkgo, biloba, etc consumption of drinks containing xanthic bases (> 0.5L/day) consumption of drinks containing plants (> 2L/day) consumption of grapefruit juice (> 0.5L/day) under current antioxidant treatment (and during last month) adult protected by the law any subject who participated to a clinical assay within the 3 months

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SODB®-physical training<br>This arm receives daily two capsules of SODB® 40mg containing 560 UI of superoxide dismutase, associated with standardized physical training | Dietary Supplement: SODB®<br>* 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<br>|
| Experimental: Placebo-physical training<br>This arm receives daily two capsules of Placebo containing excipients only, associated with standardized physical training | Dietary Supplement: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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superoxide dismutase, melon concentrate, oxidative stress, physical training