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

Bionov42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

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

PlaceboDIETARY_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

Eligibility

Sex: MALEMin age: 30 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline physical condition at 10 weeks

Evaluation performed by Ruffier test measurement

Time frame: 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)