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

Healthy Volunteers Clinical Trial

— MELORUN560  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02880657
• Other study ID #: 2016-A00302-49
• Status: Not yet recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: August 23, 2016
• Start date: September 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2016
• Source: Bionov
• Contact: Dominique Lacan
• Phone: 33(0)6 84 95 39 95
• Email: dominique.lacan[@]bionov.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• SODB®
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
• Placebo
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bionov

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events	All adverse events occured throughout the study analyzed in order to know the number of participants only with treatment-related adverse events	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	Yes
Other	Description of oxidative marker modifications in blood	Evaluation performed by KRL (Kirial test) measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Other	Description of antioxidant markers modifications in blood	Evaluation performed by antioxidant enzymes measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Other	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)	No
Other	Description of serum protein modifications in blood	Evaluation performed by Serum Protein Electrophoresis measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Other	Description of lymphocytes nature modifications in blood	Evaluation performed by lymphocytes families percent measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Other	Description of Complement blood level modifications	Evaluation performed by C3, C4 and CH50 measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Primary	Change from baseline physical condition at 10 weeks	Evaluation performed by Ruffier test measurement	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)	No
Secondary	Evaluation of cardiac frequence	Evaluation performed by measurements of cardiac frequence during a physical test	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of maximal aerobic vitesse	Evaluation performed by measurements of maximal aerobic vitesse during a physical test	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of maximal oxygen volume	Evaluation performed by measurements of maximal oxygen volume during a physical test	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of running time	Evaluation performed by measurements of running time during a physical test	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of running distance	Evaluation performed by measurements of running distance during a physical test	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of quality of fatigue	Evaluation performed by an auto scale (Prévost)	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of quality of life	Evaluation performed by an auto scale (SF36)	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of glucose blood level	Evaluation performed by glucose measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of insulin blood level	Evaluation performed by insulin measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of cholesterol level	Evaluation performed by total and LDL-cholesterol measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of triglycerides level	Evaluation performed by triglycerides measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of inflammation	Evaluation performed by CRP (C-reactive protein) measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of ions modifications	Evaluation performed by ionogram measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of creatinemia	Evaluation performed by creatinine measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of lactate level	Evaluation performed by lactate measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of transaminases level	Evaluation performed by transaminases measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of cortisol level	Evaluation performed by cortisol measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No
Secondary	Evaluation of testosterone level	Evaluation performed by testosterone measurements	Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)	No