NCT04828642

Brief Summary

This investigations aims to investigate whether supplementation with antioxidant vitamins (vitamin C and vitamin E) can influence, enhancing or blocking, the hypertrophic adaptations caused by strength training in sedentary subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

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

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

March 11, 2021

Last Update Submit

August 1, 2021

Conditions

Outcome Measures

Primary Outcomes (25)

  • DEXA

    Evaluation of muscle mass with dual energy X-ray absorptiometry

    Week 0

  • DEXA

    Evaluation of muscle mass with dual energy X-ray absorptiometry

    Week 10

  • Anthropometry

    Evaluation of muscle mass by a ISAK 1 level anthropometrist

    Week 0

  • Anthropometry

    Evaluation of muscle mass by a ISAK 1 level anthropometrist

    Week 5

  • Anthropometry

    Evaluation of muscle mass by a ISAK 1 level anthropometrist

    Week 10

  • Bioimpedance

    Evaluation of muscle mass with an Inbody

    Week 0

  • Bioimpedance

    Evaluation of muscle mass with an Inbody

    Week 5

  • Bioimpedance

    Evaluation of muscle mass with an Inbody

    Week10

  • DOMS

    Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)

    Week 0

  • DOMS

    Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)

    Week 5

  • DOMS

    Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)

    Week 10

  • Manual dinamometry

    Handgrip

    Week 0

  • Manual dinamometry

    Handgrip

    Week 5

  • Leg dinamometry

    Dinamometer

    Week 0

  • Leg dinamometry

    Dinamometer

    Week 5

  • Leg dinamometry

    Dinamometer

    Week 10

  • RPE

    10-point scale (no exertion 0- maximal effort 10)

    Week 0

  • RPE

    10-point scale (no exertion 0- maximal effort 10)

    Week 5

  • RPE

    10-point scale (no exertion 0- maximal effort 10)

    Week 10

  • 1 RM

    Bench press and squats

    Week 0

  • 1 RM

    Bench press and squats

    Week 5

  • 1 RM

    Bench press and squats

    Week 10

  • Parameters determined by ENCODER

    Bench press and squats

    Week 0

  • Parameters determined by ENCODER

    Bench press and squats

    Week 5

  • Parameters determined by ENCODER

    Bench press and squats

    Week 10

Study Arms (2)

Supplementation group

ACTIVE COMPARATOR

Antioxidant vitamins (Vitamin C (1000 mg) + Vitamine E (235 mg))

Dietary Supplement: Vitamin C and vitamin E

Placebo group

PLACEBO COMPARATOR

Placebo supplementation with the same aspect as supplementation

Dietary Supplement: Placebo

Interventions

Vitamin C and vitamin EDIETARY_SUPPLEMENT

1000 mg 235 mg

Also known as: Ascorbic acid and tocopherol
Supplementation group
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

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

You may qualify if:

  • Experience in strength training of at least one year

You may not qualify if:

  • Smokers
  • Antioxidant supplementation
  • Injuries or diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, 28011, Spain

Location

Related Publications (2)

  • Dutra MT, Martins WR, Ribeiro ALA, Bottaro M. The Effects of Strength Training Combined with Vitamin C and E Supplementation on Skeletal Muscle Mass and Strength: A Systematic Review and Meta-Analysis. J Sports Med (Hindawi Publ Corp). 2020 Jan 8;2020:3505209. doi: 10.1155/2020/3505209. eCollection 2020.

    PMID: 31970196BACKGROUND
  • Dutra MT, Alex S, Mota MR, Sales NB, Brown LE, Bottaro M. Effect of strength training combined with antioxidant supplementation on muscular performance. Appl Physiol Nutr Metab. 2018 Aug;43(8):775-781. doi: 10.1139/apnm-2017-0866. Epub 2018 Jun 25.

MeSH Terms

Conditions

Hypertrophy

Interventions

Ascorbic AcidVitamin ETocopherols

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The provider will produce the supplementation and the placebo with the same aspect, marked with numbers
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A randomized, double-blind, placebo-control, parallel controlled trial will be conducted.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
predoctoral researcher

Study Record Dates

First Submitted

March 11, 2021

First Posted

April 2, 2021

Study Start

February 1, 2021

Primary Completion

April 15, 2021

Study Completion

June 30, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations