NCT05127928

Brief Summary

Determine if acute supplementation with antioxidant vitamins (vitamin C and vitamin E) influences the muscle damage and fatigue caused after an acute session of eccentric training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2022

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

5 days

First QC Date

June 15, 2021

Last Update Submit

April 4, 2022

Conditions

Oxidative Stress

Keywords

antioxidant vitaminsoxidative damage

Outcome Measures

Primary Outcomes (22)

  • Percentage of body fat and muscle mass

    Determination of body composition using skinfolds measurements

    Prior to the intervention

  • DOMS

    Delayed onset muscle soreness. This outcome will be measure with a 10-point visual analogic scale (0= no pain; 10 = worst possible pain)

    0 hours post exercise

  • DOMS

    Delayed onset muscle soreness. This outcome will be measure with a 10-point visual analogic scale (0= no pain; 10 = worst possible pain)

    24 hours post exercise

  • Blood malondialdehyde (MDA)

    MDA will be analyzed from a blood sample

    2 hours prior to exercise

  • Blood creatine quinase (CK)

    CK will be analyzed from a blood sample

    2 hours prior to exercise

  • Blood malondialdehyde (MDA)

    MDA will be analyzed from a blood sample

    Inmediatly after exercise

  • Blood malondialdehyde (MDA)

    MDA will be analyzed from a blood sample

    24 hours after exercise

  • Blood creatine quinase (CK)

    CK will be analyzed from a blood sample

    24 hours after exercise

  • Jump height in a Counter Movement Jump

    Jump height (cm) in a counter movement jump measured with Octojump Platform

    2 hours prior to exercise

  • Jump height in a Counter Movement Jump

    Jump height (cm) in a counter movement jump measured with Octojump Platform

    Inmediatly after exercise

  • Jump height in a Counter Movement Jump

    Jump height (cm) in a counter movement jump measured with Octojump Platform

    24 h after exercise

  • Jump Height in a Squat Jump

    Jump Height (cm) in a Squat Jump measured with Octojump Platform

    24 h after exercise

  • Jump Height in a Squat Jump

    Jump Height (cm) in a Squat Jump measured with Octojump Platform

    Inmediately after exercise

  • Jump Height in a squat Jump

    Jump height (cm) in a squat jump with Octojump Platform measured with Octojump Platform

    2 hours prior to exercise

  • Jump Height in a Drop Jump

    Jump height (cm) was measured in different drop jumps with Octojump Platform

    2 hours prior to exercise

  • Jump Height in a Drop Jump

    Jump height (cm) was measured in different drop jumps with Octojump Platform

    Inmediately after exercise

  • Contact time in a Drop Jump

    Contact time (s)measured in different drop jumps with Octojump Platform

    Inmediately after exercise

  • Jump Height in a Drop Jump

    Jump height (cm) measured in different drop jumps with Octojump Platform

    Inmediately after exercise

  • Contact time in a Drop Jump

    Contact time (s) measured in different drop jumps with Octojump Platform

    24 hours after exercise

  • Jump Height in a Drop Jump

    Jump height (cm) measured in different drop jumps with Octojump Platform

    24 hours after exercise

  • Contact time in a Drop Jump

    Capillary blood lactate evaluated with Lactate Pro 2

    Inmediately after exercise

  • Concentration of blood lactate

    Capillary blood lactate with Lactate Pro 2

    2 hours before exercise

Study Arms (2)

Supplementation

EXPERIMENTAL

Vitamin C and Vitamin E before exercise

Dietary Supplement: Dietary Supplement: Vitamin C and vitamin E

Placebo

PLACEBO COMPARATOR

Placebo before exercise

Dietary Supplement: Placebo

Interventions

Dietary Supplement: Vitamin C and vitamin EDIETARY_SUPPLEMENT

Antioxidant supplementation

Also known as: Ascorbic acid and tocopherol
Supplementation
PlaceboDIETARY_SUPPLEMENT

Placebo administration

Placebo

Eligibility Criteria

Age18 Years - 33 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Physically active

You may not qualify if:

  • Injuries
  • Supplementation or drugs
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Spain

Location

MeSH Terms

Interventions

Vitamin EAscorbic AcidTocopherols

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, principal investigator

Study Record Dates

First Submitted

June 15, 2021

First Posted

November 19, 2021

Study Start

February 10, 2022

Primary Completion

February 15, 2022

Study Completion

March 6, 2022

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)