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

NCT02880657 | Unknown

• 1 other identifier: 2016-A00302-49
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Keywords

superoxide dismutase; melon concentrate; oxidative stress; physical training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 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)

Other Outcomes (7)

• Number of participants 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 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 at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)

Study Arms (2)

SODB®-physical training

EXPERIMENTAL

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

Dietary Supplement: SODB®

Placebo-physical training

EXPERIMENTAL

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

Dietary Supplement: Placebo

Interventions

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

SODB®-physical training

Placebo DIETARY_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

Placebo-physical training

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ruffier score between 8 and 12
• \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bionov: lead

Study Officials

• Claire Thalamas

  CIC Hospital Purpan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Lacan

CONTACT

33(0)6 84 95 39 95; dominique.lacan@bionov.fr

Julie Carillon

CONTACT

33(0)6 40 20 14 78; jc.rech@bionov.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 26, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: August 1, 2018
• Last Updated: August 26, 2016

Record last verified: 2016-08