Evaluation of SODB® (Superoxide Dismutase by Bionov®) in the Physical Condition Improvement in Healthy Subjects (MELORUN560)

Bionov

Status: Unknown

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: SODB®; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02880657

2016-A00302-49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: Male

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

SODB®-physical training

Experimental group

Description:

This arm receives daily two capsules of SODB® 40mg containing 560 UI of superoxide dismutase, associated with standardized physical training

Treatment:

Dietary Supplement: SODB®

Placebo-physical training

Experimental group

Description:

This arm receives daily two capsules of Placebo containing excipients only, associated with standardized physical training

Treatment:

Dietary Supplement: Placebo