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

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: SODB®; Dietary supplement: 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 Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique Lacan; Phone Number: 33(0)6 84 95 39 95; Email: dominique.lacan@bionov.fr
• Study Contact Backup: Name: Julie Carillon; Phone Number: 33(0)6 40 20 14 78; Email: jc.rech@bionov.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SODB®-physical training; This arm receives daily two capsules of SODB® 40mg containing 560 UI of superoxide dismutase, associated with standardized physical training	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
Experimental: Placebo-physical training; This arm receives daily two capsules of Placebo containing excipients only, associated with standardized physical training	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Bionov
• Investigators: Principal Investigator: Claire Thalamas, CIC Hospital Purpan

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Estimate): August 26, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: oxidative stress; melon concentrate; physical training; superoxide dismutase
• Other Study ID Numbers: 2016-A00302-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided