Exercise PerformancePhytoDyNAmicNCT04263246
Medium-Term Supplementation With Herbal Extract for Exercise Performance and Antioxidant Status
A study testing PhytoDyNAmic and Inulin in people with Exercise Performance, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
We evaluated here the effects of 6-week intervention with herbal supplement on exercise performance outcomes and serum biomarkers of antioxidant status. In addition, we also assessed the long-term effects (6-month) of the intervention in elderly adults. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- PhytoDyNAmic and Inulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Sep 2020to 1 Dec 2020
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Body mass index 19 - 25 kg/m2
- Free of major chronic diseases or acute disorders
Who cannot join
- Use of dietary supplements within 4 weeks before study commences
- Unwillingness to return for follow-up analysis
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000
About this study
Official title: Does Medium-Term Supplementation With PhytoDyNAmic Affect Exercise Performance and Antioxidant Status in Healthy Men and Women: A Randomized Controlled Trial?
We evaluated here the effects of 6-week intervention with herbal supplement on exercise performance outcomes and serum biomarkers of antioxidant status. In addition, we also assessed the long-term effects (6-month) of the intervention in elderly adults.
Read the detailed description
Experimental protocol
- 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
- Exercise Performance
- Being tested
- PhytoDyNAmic, Inulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytoDyNAmicDietary supplement
PhytoDyNAmic (6 capsules per day)
InulinDietary supplement
Inulin (6 capsules per day)
| Study group | Role | What they receive |
|---|---|---|
| PhytoDyNAmic | Experimental | Six capsules per day b.i.d. Receives: Dietary Supplement: PhytoDyNAmic |
| Inulin | Placebo comparator | Six capsules per day b.i.d. Receives: Dietary Supplement: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to exhaustion
Baseline vs. 6 weeks
Measured: Baseline vs. 6 weeks post-intervention
Secondary outcomes (3)
Change in serum superoxide dismutase
Baseline vs. 6 weeks
Measured: Baseline vs. 6 weeks post-intervention
Change in serum total antioxidant capacity
Baseline vs. 6 weeks
Measured: Baseline vs. 6 weeks post-intervention
Change in serum telomerase activity
Baseline vs. 6 weeks
Measured: Baseline vs. 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start15 Sep 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
- Investigators
- Nebojsa Maksimovic, PhD, Study chair, Faculty of Sport and PE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263246
- Sponsor's protocol ID
- 320-PDY/2019
- Acronym
- PhytoDyNAmic
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2020
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Medium-Term Supplementation With PhytoDyNAmic Affect Exercise Performance and Antioxidant Status in Healthy Men and Women: A Randomized Controlled Trial?
- ClinicalTrials.gov ID
- NCT04263246
- Acronym / sponsor ID
- PhytoDyNAmic / 320-PDY/2019
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 10 Feb 2020 (actual)
- 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.
We evaluated here the effects of 6-week intervention with herbal supplement on exercise performance outcomes and serum biomarkers of antioxidant status. In addition, we also assessed the long-term effects (6-month) of the intervention in elderly adults.
Detailed description
Experimental protocol
- 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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PhytoDyNAmic | Experimental | Dietary Supplement: PhytoDyNAmicSix capsules per day b.i.d. |
| Inulin | Placebo comparator | Dietary Supplement: InulinSix capsules per day b.i.d. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Body mass index 19 - 25 kg/m2
- Free of major chronic diseases or acute disorders
Key exclusion criteria (2 listed)
- Use of dietary supplements within 4 weeks before study commences
- Unwillingness to return for follow-up analysis
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 |
|---|---|---|
| PhytoDyNAmicPhytoDyNAmic (6 capsules per day) | Dietary supplement | PhytoDyNAmic |
| InulinInulin (6 capsules per day) | Dietary supplement | Inulin |
Primary outcome
Change in time to exhaustion
Time frame: Baseline vs. 6 weeks post-intervention
Baseline vs. 6 weeks
3 secondary outcomes
Change in serum superoxide dismutase
Time frame: Baseline vs. 6 weeks post-intervention
Change in serum total antioxidant capacity
Time frame: Baseline vs. 6 weeks post-intervention
Change in serum telomerase activity
Time frame: Baseline vs. 6 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Nebojsa Maksimovic, PhD study chair
Faculty of Sport and PE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PhytoDyNAmic and Inulin in people with Exercise Performance, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to exhaustion (time frame: Baseline vs. 6 weeks post-intervention). 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 25 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.