Clinical trial NCT02880657: Evaluation of SODB® (Superoxide Dismutase by Bionov®) in the Physical Condition Improvement in Healthy Subjects
Official title: Evaluation of SODB®, Associated With a Physical Training, in the Physical Condition Improvement in Healthy Subjects: Randomized Double-blind Study Versus Placebo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: superoxide dismutase
melon concentrate
oxidative stress
physical training
Lead sponsor: Bionov
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 42
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline physical condition at 10 weeks
timeFrame: 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 outcomes:
measure: Evaluation of cardiac frequence
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of maximal aerobic vitesse
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of maximal oxygen volume
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of running time
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of running distance
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of quality of fatigue
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of quality of life
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of glucose blood level
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of insulin blood level
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of cholesterol level
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of triglycerides level
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of inflammation
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of ions modifications
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of creatinemia
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of lactate level
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of transaminases level
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of cortisol level
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Evaluation of testosterone level
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Other outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Description of oxidative marker modifications in blood
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Description of antioxidant markers modifications in blood
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Description of Complete Blood Count modifications in blood
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Description of serum protein modifications in blood
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Description of lymphocytes nature modifications in blood
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
measure: Description of Complement blood level modifications
timeFrame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Locations:
Study officials:
affiliation: CIC Hospital Purpan
name: Claire Thalamas
role: PRINCIPAL_INVESTIGATOR
References: