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Clinical Trials/NCT02880657
NCT02880657UnknownNot Applicable

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

Bionov0 sites42 target enrollmentStarted: September 1, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Bionov
Enrollment
42
Primary Endpoint
Change from baseline physical condition at 10 weeks
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 45 Years (Adult)
Sex
Male
Accepts 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

Arms & Interventions

SODB®-physical training

Experimental

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

Intervention: SODB® (Dietary Supplement)

Placebo-physical training

Experimental

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

Intervention: Placebo (Dietary Supplement)

Outcomes

Primary Outcomes

Change from baseline physical condition at 10 weeks

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)

Evaluation performed by Ruffier test measurement

Secondary Outcomes

  • Evaluation of cardiac frequence(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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
  • 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 of running time(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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
  • 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 of quality of life(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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
  • 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 of cholesterol level(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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
  • Evaluation of testosterone level(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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
  • Evaluation of inflammation(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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
  • Evaluation of creatinemia(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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
  • Evaluation of transaminases level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))

Investigators

Sponsor
Bionov
Sponsor Class
Industry
Responsible Party
Sponsor

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