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

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.

Study Overview

• Status: Completed
• Conditions: Exercise Performance
• Intervention / Treatment: Dietary supplement: PhytoDyNAmic; Dietary supplement: Inulin

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Applied Bioenergetics Lab at Faculty of Sport and PE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PhytoDyNAmic; Six capsules per day b.i.d.	Dietary supplement: PhytoDyNAmic; PhytoDyNAmic (6 capsules per day)
Placebo Comparator: Inulin; Six capsules per day b.i.d.	Dietary supplement: Inulin; Inulin (6 capsules per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in time to exhaustion	Baseline vs. 6 weeks	Baseline vs. 6 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum superoxide dismutase	Baseline vs. 6 weeks	Baseline vs. 6 weeks post-intervention
Change in serum total antioxidant capacity	Baseline vs. 6 weeks	Baseline vs. 6 weeks post-intervention
Change in serum telomerase activity	Baseline vs. 6 weeks	Baseline vs. 6 weeks post-intervention

Collaborators and Investigators

• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 320-PDY/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No