Healthy Volunteers
Conditions
Keywords
superoxide dismutase, melon concentrate, oxidative stress, physical training
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTSODB®
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
DIETARY_SUPPLEMENTPlacebo
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
Sponsors
Bionov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
30 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline physical condition at 10 weeks | 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) | Evaluation performed by Ruffier test measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of running time | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by measurements of running time during a physical test |
| Evaluation of inflammation | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by CRP (C-reactive protein) measurements |
| Evaluation of ions modifications | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by ionogram measurements |
| Evaluation of creatinemia | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by creatinine measurements |
| Evaluation of lactate level | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by lactate measurements |
| Evaluation of transaminases level | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by transaminases measurements |
| Evaluation of cortisol level | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by cortisol measurements |
| Evaluation of testosterone level | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by testosterone measurements |
| Evaluation of insulin blood level | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by insulin measurements |
| Evaluation of cholesterol level | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by total and LDL-cholesterol measurements |
| Evaluation of triglycerides level | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by triglycerides measurements |
| Evaluation of cardiac frequence | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by measurements of cardiac frequence during a physical test |
| Evaluation of maximal aerobic vitesse | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by measurements of maximal aerobic vitesse during a physical test |
| Evaluation of maximal oxygen volume | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by measurements of maximal oxygen volume during a physical test |
| Evaluation of running distance | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by measurements of running distance during a physical test |
| Evaluation of quality of fatigue | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by an auto scale (Prévost) |
| Evaluation of quality of life | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by an auto scale (SF36) |
| Evaluation of glucose blood level | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by glucose measurements |
Other
| Measure | Time frame | Description |
|---|---|---|
| Description of antioxidant markers modifications in blood | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by antioxidant enzymes measurements |
| 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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by Serum Protein Electrophoresis measurements |
| Description of lymphocytes nature modifications in blood | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by lymphocytes families percent measurements |
| Description of Complement blood level modifications | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | Evaluation performed by C3, C4 and CH50 measurements |
| Number of participants with treatment-related adverse events | Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4) | All adverse events occured throughout the study analyzed in order to know the number of participants only with treatment-related adverse events |
| Description of oxidative marker modifications in blood | 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 |
Contacts
Primary ContactDominique Lacan
Backup ContactJulie Carillon
Outcome results
None listed