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

Not Applicable

Completed

• Conditions: Exercise Performance
• Interventions: Dietary Supplement: PhytoDyNAmic; Dietary Supplement: Inulin

• Registration Number: NCT04263246
• Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

Brief 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.

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 Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Study Start: 2020-09-15
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PhytoDyNAmic	PhytoDyNAmic	Six capsules per day b.i.d.
Inulin	Inulin	Six capsules per day b.i.d.

Primary Outcome Measures

Name	Time	Method
Change in time to exhaustion	Baseline vs. 6 weeks post-intervention	Baseline vs. 6 weeks

Secondary Outcome Measures

Name	Time	Method
Change in serum superoxide dismutase	Baseline vs. 6 weeks post-intervention	Baseline vs. 6 weeks
Change in serum telomerase activity	Baseline vs. 6 weeks post-intervention	Baseline vs. 6 weeks
Change in serum total antioxidant capacity	Baseline vs. 6 weeks post-intervention	Baseline vs. 6 weeks

Trial Locations

Locations (1)

Applied Bioenergetics Lab at Faculty of Sport and PE; 🇷🇸 Novi Sad, Vojvodina, Serbia