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Completed

NCT Number: NCT04263246

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

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.

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Key information

Conditions

Exercise Performance

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PhytoDyNAmic

Dietary Supplement

PhytoDyNAmic (6 capsules per day)

Inulin

Dietary Supplement

Inulin (6 capsules per day)

Primary outcomes

  1. Change in time to exhaustion

    Time frame: Baseline vs. 6 weeks post-intervention

    Baseline vs. 6 weeks

Secondary outcomes

  1. Change in serum superoxide dismutase

    Time frame: Baseline vs. 6 weeks post-intervention

    Baseline vs. 6 weeks

  2. Change in serum total antioxidant capacity

    Time frame: Baseline vs. 6 weeks post-intervention

    Baseline vs. 6 weeks

  3. Change in serum telomerase activity

    Time frame: Baseline vs. 6 weeks post-intervention

    Baseline vs. 6 weeks

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study title

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

Acronym: PhytoDyNAmic

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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