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

NCT ID: NCT04263246

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2020-12-01

Brief Summary

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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

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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)

Conditions

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Exercise Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PhytoDyNAmic

Six capsules per day b.i.d.

Group Type EXPERIMENTAL

PhytoDyNAmic

Intervention Type DIETARY_SUPPLEMENT

PhytoDyNAmic (6 capsules per day)

Inulin

Six capsules per day b.i.d.

Group Type PLACEBO_COMPARATOR

Inulin

Intervention Type DIETARY_SUPPLEMENT

Inulin (6 capsules per day)

Interventions

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PhytoDyNAmic

PhytoDyNAmic (6 capsules per day)

Intervention Type DIETARY_SUPPLEMENT

Inulin

Inulin (6 capsules per day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Novi Sad, Faculty of Sport and Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Sergej Ostojic

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nebojsa Maksimovic, PhD

Role: STUDY_CHAIR

Faculty of Sport and PE

Locations

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Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, Serbia

Site Status

Countries

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Serbia

Other Identifiers

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320-PDY/2019

Identifier Type: -

Identifier Source: org_study_id

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