Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000319774
Ethics application status
Approved
Date submitted
25/11/2021
Date registered
21/02/2022
Date last updated
21/02/2022
Date data sharing statement initially provided
21/02/2022
Date results information initially provided
21/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of supplementation with orally effective Superoxide Dismutase, GliSODin, on oxidative stress, inflammation and performance in athletes
Scientific title
Evaluation of antioxidant and anti-inflammatory properties of orally effective plant origin Superoxide Dismutase, GliSODin, supplementation and its impact on performance in athletes
Secondary ID [1] 305874 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise performance 324421 0
Exercise induced oxidative stress 324422 0
Exercise induced inflammation 324423 0
Condition category
Condition code
Alternative and Complementary Medicine 321919 321919 0 0
Other alternative and complementary medicine
Musculoskeletal 322406 322406 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplementation with plant origin superoxide dismutase (GliSODin) in a randomized, double-blind, placebo controlled study conducted to assess the effects of supplementation on exercise-induced oxidative stress, exercise-induced inflammation and performance in athletes. Study included group of elite rowers and group of recreational athletes. For all rowers participating this study exercise performance was tested on rowing ergometer at the beginning of the study. Test on ergometer was conducted with increased exercise load. For males it was 2 minutes rowing with increasing load for every session like this: 150W (watt), 200W, 250W, 300W, 400W , and individual maximal effort, with 5 minutes pauses between session and 8 minutes pause before maximal effort attempt. For females load increased like this: 150W, 180W, 220W, 250W, 300W , and individual maximal effort, with same pause schema. Test on rowing ergometer lasted for 40 minutes. Rowers trainers and medical technician, beside research team, were monitoring the test. Same test was conduced after 6 weeks of supplementation. During this 6 weeks rowers were training according to the schedule determined by their trainers, once daily, 6 or 7 days a week, duration of every training session was 1 hour and 30 minutes. After initial testing, rowers have been taking GliSODin (250mg), 2 capsules every day, one hour before training on days with training or one hour before breakfast on days without training, during 6 weeks period. Sport performance of recreational athletes was tested at the beginning of the study on a treadmill machine. All athletes were running for 30 minutes on 70-75% of VO2max and after that they have done usual training in a gym. After initial testing, recreational athletes have been taking 2 capsules of GliSodin (250mg) only on the days they were having training (3 times a week), one hour before training, during 6 weeks. Training load was individualized for each athlete by personal coach with incremental increase in training load. Recreational athlete had 3 training sessions a week for 6 weeks, duration of sessions was 1 hour. All participant were asked to avoid using any other supplement or medicines. Every use of medicines must have been reported to research team. Intervention adherence was monitored by capsules returned to the research team and by trainers whose task was to lead the record of training for every participant.
Intervention code [1] 322272 0
Treatment: Other
Intervention code [2] 322646 0
Prevention
Comparator / control treatment
Placebo is containing maltodextrin instead of active compound. It is matched to GliSODin capsules in term of appearance but does not contain active ingredient.Study included group of elite rowers and group of recreational athletes. Both groups separately were randomly divided to experimental and control (placebo) group.
Control group
Placebo

Outcomes
Primary outcome [1] 329681 0
Exercise performance measured by testing on rowing ergometer or treadmill machine. Exercise performance of rowers was measured by average strength used for 2 minutes maximum effort rowing session, expressed in watt(W). For recreational athletes exercise performance was measured by distance crossed by running on treadmill machine on 70-75% of VO2max for 30 minutes.
Timepoint [1] 329681 0
Baseline (before supplementation), after 6 weeks of supplementation
Secondary outcome [1] 403422 0
Complete blood count (CBC)
Timepoint [1] 403422 0
Baseline (before supplementation) and after 6 weeks of supplementation. At each timepoint samples was taken only before training session (on rowing ergometer or treadmill machine).
Secondary outcome [2] 403423 0
serum total cholesterol (TC)
Timepoint [2] 403423 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [3] 403424 0
serum triglyceride (TG)
Timepoint [3] 403424 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [4] 403426 0
Change in liver function, assessed by total bilirubin (TB), serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT)
Timepoint [4] 403426 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [5] 403427 0
Change in renal function, assessed by serum urea concentration, serum creatinin level, serum albumin and total protein level, serum uric acid level
Timepoint [5] 403427 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [6] 403428 0
level of serum glucose
Timepoint [6] 403428 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [7] 403429 0
status of iron, assessed by serum iron, total iron-binding capacity (TIBC), ferritin
Timepoint [7] 403429 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [8] 403430 0
serum C-reactive protein (CRP) level
Timepoint [8] 403430 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [9] 403431 0
serum creatine kinase (CK) level
Timepoint [9] 403431 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [10] 403432 0
serum lactate dehydrogenase (LDH) level
Timepoint [10] 403432 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [11] 403433 0
serum total antioxidant status (TAS)
Timepoint [11] 403433 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [12] 403434 0
serum total oxidant status (TOS)
Timepoint [12] 403434 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [13] 403435 0
serum superoxide dismutase (SOD) level
Timepoint [13] 403435 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [14] 403436 0
serum glutathione peroxidase (GPx) level
Timepoint [14] 403436 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [15] 403437 0
serum interleukin 6 ( IL-6) level
Timepoint [15] 403437 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [16] 403438 0
serum interleukin 8 ( IL-8) level
Timepoint [16] 403438 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [17] 403439 0
serum interleukin 10 ( IL-10) level
Timepoint [17] 403439 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [18] 403440 0
serum interleukin 4 ( IL-4) level
Timepoint [18] 403440 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine)
Secondary outcome [19] 403441 0
serum zonulin level
Timepoint [19] 403441 0
Baseline (before supplementation), after 6 weeks of supplementation. At each timepoint samples was taken before and 10 minutes after training session (on rowing ergometer or treadmill machine).
Secondary outcome [20] 405151 0
Eating patterns of athletes was assessed using 5- day food record diary
Timepoint [20] 405151 0
5 days during first week of supplementation period,
Secondary outcome [21] 405152 0
Changes in lactate level, measured by single drop of blood taken from a finger prick on to the lactate test strips.
Timepoint [21] 405152 0
Baseline(before supplementation) and after 6 weeks of supplementation. At each timepoint, samples was taken as follows during ergometer training: before training,1 minute after each 2-minute rowing session, and 1, 3, and 5 minutes after 2 minutes of maximal effort rowing. For recreational athletes samples was taken before training and 3 and 5 minutes after training.

Eligibility
Key inclusion criteria
Healthy elite athletes and healthy fit people without any acute infection, injury or some chronic diseases like diabetes, cardiovascular, renal or gastrointestinal diseases
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
allergy to any component of dietary supplement, gluten intolerance, supplementation with other antioxidant supplement during the study and two weeks before study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a
statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/12/2020
Date of last participant enrolment
Anticipated
Actual
3/09/2021
Date of last data collection
Anticipated
Actual
16/10/2021
Sample size
Target
60
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 24347 0
Serbia and Montenegro
State/province [1] 24347 0
Serbia

Funding & Sponsors
Funding source category [1] 310224 0
University
Name [1] 310224 0
University of Belgrade - Faculty of Pharmacy
Country [1] 310224 0
Serbia and Montenegro
Primary sponsor type
Individual
Name
Ivan Stankovic
Address
University of Belgrade – Faculty of Pharmacy
Vojvode Stepe 450, 11221 Belgrade, Serbia
Country
Serbia and Montenegro
Secondary sponsor category [1] 311321 0
Individual
Name [1] 311321 0
Milivoj Dopsaj
Address [1] 311321 0
University of Belgrade - Faculty of Sport and Physical Education
Blagoja Parovica 156, 11030 Belgrade, Serbia
Country [1] 311321 0
Serbia and Montenegro
Other collaborator category [1] 282078 0
Commercial sector/Industry
Name [1] 282078 0
IsoCell NUTRA
Address [1] 282078 0
53 Boulevard du General Martial Valin, 74015, Paris, France
Country [1] 282078 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309908 0
Ethical Committee of Faculty of Pharmacy, Belgrade
Ethics committee address [1] 309908 0
University of Belgrade – Faculty of Pharmacy
Vojvode Stepe 450, 11221 Belgrade, Serbia
Ethics committee country [1] 309908 0
Serbia and Montenegro
Date submitted for ethics approval [1] 309908 0
03/12/2020
Approval date [1] 309908 0
15/12/2020
Ethics approval number [1] 309908 0
2192/2

Summary
Brief summary
Intensive physical activity can cause oxidative stress witch is connected with some inflammation reaction and higher muscle fatigue and injury level so it can reduce performance of athletes. GliSODin is dietary supplement that contain plant origin superoxide dismutase (SOD). SOD is one of the main antioxidant enzymes in our body. In our randomized, double-blind, placebo-controlled study we were investigating if supplementation with GliSODin can reduce side effects of oxidative stress induced by intensive physical activity and increase physical performance of elite athletes or healthy fit people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115794 0
Prof Ivan Stankovic
Address 115794 0
University of Belgrade – Faculty of Pharmacy
Vojvode Stepe 450, 11221 Belgrade, Serbia
Country 115794 0
Serbia and Montenegro
Phone 115794 0
+381641373184
Fax 115794 0
Email 115794 0
[email protected]
Contact person for public queries
Name 115795 0
Olina Dudašova Petrovicova
Address 115795 0
University of Belgrade – Faculty of Pharmacy
Vojvode Stepe 450, 11221 Belgrade, Serbia
Country 115795 0
Serbia and Montenegro
Phone 115795 0
+381638501761
Fax 115795 0
Email 115795 0
[email protected]
Contact person for scientific queries
Name 115796 0
Olina Dudasova Petrovicova
Address 115796 0
University of Belgrade – Faculty of Pharmacy
Vojvode Stepe 450, 11221 Belgrade, Serbia
Country 115796 0
Serbia and Montenegro
Phone 115796 0
+381638501761
Fax 115796 0
Email 115796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All document and data connected to this study is in Serbian language so it would not be understandable for reading, we do not have translations to English language for this data so far.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHow Supplementation with SOD-Rich Plant Extract, Combined with Gliadin, Can Affect Oxidative Stress Markers and Zonulin Levels in Exercise-Induced Oxidative Stress.2023https://dx.doi.org/10.3390/metabo13121200
N.B. These documents automatically identified may not have been verified by the study sponsor.