Medium-Term Supplementation With Herbal Extract for Exercise Performance and Antioxidant Status
NCT ID: NCT04263246
Last Updated: 2022-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2020-09-15
2020-12-01
Brief Summary
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Detailed Description
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* Double-blind, randomized, placebo-controlled cross-over trial
* 6-week intervention trial (with additiional follow-up arm after 6 months)
* Experimental intervention (PhytoDyNAmic) = 6 capsules per day
* Placebo (inulin) = 1 g per day b.i.d.
* Administration = 3 capsules with breakfast and 3 capsules with dinner
* Wash-out period = 2 weeks
* No changes in physical activity patterns and diet during the study
Outcomes assessed at baseline and at each follow-up:
* Exercise performance during incremental running-to-exhaustion test
* Serum biomarkers of antioxidant status
* Total antioxidant capacity (TAC)
* Superoxide dismutase (SOD)
* Telomerase activity
Early termination criteria
\- Serious subjective side effects of an intervention (e.g. nausea, vomiting, bloating)
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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PhytoDyNAmic
Six capsules per day b.i.d.
PhytoDyNAmic
PhytoDyNAmic (6 capsules per day)
Inulin
Six capsules per day b.i.d.
Inulin
Inulin (6 capsules per day)
Interventions
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PhytoDyNAmic
PhytoDyNAmic (6 capsules per day)
Inulin
Inulin (6 capsules per day)
Eligibility Criteria
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Inclusion Criteria
* Body mass index 19 - 25 kg/m2
* Free of major chronic diseases or acute disorders
Exclusion Criteria
* Unwillingness to return for follow-up analysis
20 Years
75 Years
ALL
Yes
Sponsors
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University of Novi Sad, Faculty of Sport and Physical Education
OTHER
Responsible Party
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Sergej Ostojic
Professor
Principal Investigators
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Nebojsa Maksimovic, PhD
Role: STUDY_CHAIR
Faculty of Sport and PE
Locations
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Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, Serbia
Countries
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Other Identifiers
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320-PDY/2019
Identifier Type: -
Identifier Source: org_study_id
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