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NCT04263246 Clinical Trial

Medium-Term Supplementation With Herbal Extract for Exercise Performance and Antioxidant Status

Exercise Performance Clinical Trial

— PhytoDyNAmic  

Official title:
Does Medium-Term Supplementation With PhytoDyNAmic Affect Exercise Performance and Antioxidant Status in Healthy Men and Women: A Randomized Controlled Trial?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04263246
Other study ID # 320-PDY/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 1, 2020

Study information
Verified date March 2022
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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)

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - Age = 18 years - Body mass index 19 - 25 kg/m2 - Free of major chronic diseases or acute disorders Exclusion Criteria: - Use of dietary supplements within 4 weeks before study commences - Unwillingness to return for follow-up analysis

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• PhytoDyNAmic
PhytoDyNAmic (6 capsules per day)
• Inulin
Inulin (6 capsules per day)

Locations
Country Name City State
Serbia Applied Bioenergetics Lab at Faculty of Sport and PE Novi Sad Vojvodina

Sponsors (1)
Lead Sponsor Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in time to exhaustion Baseline vs. 6 weeks Baseline vs. 6 weeks post-intervention
Secondary Change in serum superoxide dismutase Baseline vs. 6 weeks Baseline vs. 6 weeks post-intervention
Secondary Change in serum total antioxidant capacity Baseline vs. 6 weeks Baseline vs. 6 weeks post-intervention
Secondary Change in serum telomerase activity Baseline vs. 6 weeks Baseline vs. 6 weeks post-intervention
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