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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Exercise Performance

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