NCT02726516

Brief Summary

Compare a dietary supplement (PRJ-205) and placebo during 1 or 4 days on aerobic exercise performance, oxidative stress and muscle damage. The hypothesis is that supplementation with PRJ-205 improve aerobic performance

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable healthy

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

Study Start

First participant enrolled

March 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

March 23, 2016

Last Update Submit

November 30, 2016

Conditions

Healthy

Keywords

Performance

Outcome Measures

Primary Outcomes (1)

  • Aerobic performance determined by VO2max

    4 days

Secondary Outcomes (3)

  • Pressure pain threshold of calf muscle

    4 days

  • Serum markers of muscular damage

    4 days

  • Oxidative stress parameters

    4 days

Study Arms (2)

Treated

EXPERIMENTAL

Treated volunteers will be administered one dose of PRJ-205 1,5 hours before the exercise task for the acute testing and will be taking one dose per day of PRJ-205 for 4 days for the chronic testing.

Dietary Supplement: PRJ-205

Placebo

PLACEBO COMPARATOR

Placebo volunteers will be administered one dose of placebo 1,5 hours before the exercise task for the acute testing and will be taking one dose per day of placebo for 4 days for the chronic testing.

Other: Placebo

Interventions

PRJ-205DIETARY_SUPPLEMENT

1 sachet per day

Treated
PlaceboOTHER

1 sachet per day

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Healthy
  • Physically active

You may not qualify if:

  • known cardiovascular, pulmonary or metabolic disease
  • any medical condition that could affect the development and safety of the exercise task

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Valencia

Valencia, Valencia, 46010, Spain

Location

Study Officials

  • Jose Viña, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 1, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

ES(1)