Healthy VolunteersMELORUN560NCT02880657
Evaluation of SODB® (Superoxide Dismutase by Bionov®) in the Physical Condition Improvement in Healthy Subjects
A study testing SODB® in people with Healthy Volunteers, run by Robertet SA.
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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SODB®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- SODB®, Placebo
- Keywords
- superoxide dismutase, melon concentrate, oxidative stress, physical training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| SODB®-physical training | Experimental | This arm receives daily two capsules of SODB® 40mg containing 560 UI of superoxide dismutase, associated with standardized physical training Receives: Dietary Supplement: SODB® |
| Placebo-physical training | Experimental | This arm receives daily two capsules of Placebo containing excipients only, associated with standardized physical training Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline physical condition at 10 weeks
Evaluation performed by Ruffier test measurement
Measured: 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 outcomes (18)
Evaluation of cardiac frequence
Evaluation performed by measurements of cardiac frequence during a physical test
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robertet SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claire Thalamas, Principal investigator, CIC Hospital Purpan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880657
- Sponsor's protocol ID
- 2016-A00302-49
- Acronym
- MELORUN560
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SODB®, Associated With a Physical Training, in the Physical Condition Improvement in Healthy Subjects: Randomized Double-blind Study Versus Placebo
- ClinicalTrials.gov ID
- NCT02880657
- Acronym / sponsor ID
- MELORUN560 / 2016-A00302-49
- Conditions
- Healthy Volunteers
- Keywords
- superoxide dismutase, melon concentrate, oxidative stress, physical training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Robertet SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SODB®-physical training | Experimental | Dietary Supplement: SODB®This arm receives daily two capsules of SODB® 40mg containing 560 UI of superoxide dismutase, associated with standardized physical training |
| Placebo-physical training | Experimental | Dietary Supplement: PlaceboThis arm receives daily two capsules of Placebo containing excipients only, associated with standardized physical training |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | SODB®-physical training |
| PlaceboSubjects 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 | Dietary supplement | Placebo-physical training |
Primary outcome
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
18 secondary outcomes
Evaluation of cardiac frequence
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of maximal aerobic vitesse
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of maximal oxygen volume
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of running time
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of running distance
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of quality of fatigue
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of quality of life
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of glucose blood level
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of insulin blood level
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of cholesterol level
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of triglycerides level
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of inflammation
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of ions modifications
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of creatinemia
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of lactate level
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of transaminases level
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of cortisol level
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Evaluation of testosterone level
Time frame: Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Thalamas principal investigator
CIC Hospital Purpan
Questions about this trial
What is this clinical trial studying?
A study testing SODB® in people with Healthy Volunteers, run by Robertet SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Lacan (33(0)6 84 95 39 95, dominique.lacan@bionov.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.