NCT04263246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

February 7, 2020

Last Update Submit

March 9, 2022

Conditions

Exercise Performance

Outcome Measures

Primary Outcomes (1)

  • Change in time to exhaustion

    Baseline vs. 6 weeks

    Baseline vs. 6 weeks post-intervention

Secondary Outcomes (3)

  • Change in serum superoxide dismutase

    Baseline vs. 6 weeks post-intervention

  • Change in serum total antioxidant capacity

    Baseline vs. 6 weeks post-intervention

  • Change in serum telomerase activity

    Baseline vs. 6 weeks post-intervention

Study Arms (2)

PhytoDyNAmic

EXPERIMENTAL

Six capsules per day b.i.d.

Dietary Supplement: PhytoDyNAmic

Inulin

PLACEBO COMPARATOR

Six capsules per day b.i.d.

Dietary Supplement: Inulin

Interventions

PhytoDyNAmicDIETARY_SUPPLEMENT

PhytoDyNAmic (6 capsules per day)

PhytoDyNAmic
InulinDIETARY_SUPPLEMENT

Inulin (6 capsules per day)

Inulin

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Body mass index 19 - 25 kg/m2
  • Free of major chronic diseases or acute disorders

You may not qualify if:

  • Use of dietary supplements within 4 weeks before study commences
  • Unwillingness to return for follow-up analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Nebojsa Maksimovic, PhD

    Faculty of Sport and PE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 10, 2020

Study Start

September 15, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)