Antioxidant Vitaminas and Hypertrophy Adaptations to Resistance Training

August 1, 2021 updated by: María Martínez Ferrán, Universidad Europea de Madrid

Vitamins C and Vitamin E and Hypertrophy Adaptations to Resistance Traini

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A randomized, double-blind, placebo-control controlled trial will be conducted. In a previous session volunteers will be interviewed to determine if they meet the inclusion criteria. Will be done two weeks of flushing out other types of supplementation and strenuous physical exercise, along with familiarization with the strength training program and performance tests to be carried out during the rehearsal. Subsequently, it will be a week without exercising to start with the experimental designs. From the start of the trial, participants should avoid physical exercise. strenuous outside the training protocol and if usual, they will only be able to perform one resistance training session per week. Participants should avoid ingesting of foods that contain high amounts of antioxidant compounds: more than two juices of fruits, more than four cups of coffee or tea. Juices with high antioxidant content should be avoided. Alcoholic beverages should also be avoided.

  • Group 1 (G1): Antioxidant vitamins (VitC (1000 mg) + VitE (235 mg)) + exercise
  • Group 2 (G2): Placebo + exercise A supplementation period of 12 weeks will be carried out. In each period, supplementation with antioxidant vitamins: VitC (1000 mg) + VitE (235 mg) or with placebo.

All participants will ingest the supplementation between 1-3 hours before training, the days of rest in the mornings.

All participants will perform a 12-week strength training protocol. The training session performed in the sharp design will be the first training session in chronic design. Being the baseline (E0) and post-exercise (E1) assessment performed in G1, G2 and G3 also the first evaluation corresponding to the chronic design.

In the middle of the supplementation period (week 6) and at the end, two new evaluations (week 12). Baseline evaluations will be performed prior to an exercise session of week 6 (E2) and at the last exercise session (E3) of the following parameters: performance physique, body composition, micronutrient analysis, muscle ultrasound. I also know conduct post-exercise physical performance assessments Figure 2.

The strength training protocol will be carried out 4 days a week at the facilities sports of the European University. The sessions will be planned by a professional from the Sciences of Physical Activity and Sports. Sessions will be tracked through a diary.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28011
        • Universidad Europea de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Experience in strength training of at least one year

Exclusion Criteria:

  • Smokers
  • Antioxidant supplementation
  • Injuries or diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Supplementation group
Antioxidant vitamins (Vitamin C (1000 mg) + Vitamine E (235 mg))
Dietary supplement: Vitamin C and vitamin E
1000 mg 235 mg
Other Names:
  • Ascorbic acid and tocopherol
PLACEBO_COMPARATOR: Placebo group
Placebo supplementation with the same aspect as supplementation
Dietary supplement: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DEXA
Time Frame: Week 0
Evaluation of muscle mass with dual energy X-ray absorptiometry
Week 0
DEXA
Time Frame: Week 10
Evaluation of muscle mass with dual energy X-ray absorptiometry
Week 10
Anthropometry
Time Frame: Week 0
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Week 0
Anthropometry
Time Frame: Week 5
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Week 5
Anthropometry
Time Frame: Week 10
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Week 10
Bioimpedance
Time Frame: Week 0
Evaluation of muscle mass with an Inbody
Week 0
Bioimpedance
Time Frame: Week 5
Evaluation of muscle mass with an Inbody
Week 5
Bioimpedance
Time Frame: Week10
Evaluation of muscle mass with an Inbody
Week10
DOMS
Time Frame: Week 0
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Week 0
DOMS
Time Frame: Week 5
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Week 5
DOMS
Time Frame: Week 10
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Week 10
Manual dinamometry
Time Frame: Week 0
Handgrip
Week 0
Manual dinamometry
Time Frame: Week 5
Handgrip
Week 5
Leg dinamometry
Time Frame: Week 0
Dinamometer
Week 0
Leg dinamometry
Time Frame: Week 5
Dinamometer
Week 5
Leg dinamometry
Time Frame: Week 10
Dinamometer
Week 10
RPE
Time Frame: Week 0
10-point scale (no exertion 0- maximal effort 10)
Week 0
RPE
Time Frame: Week 5
10-point scale (no exertion 0- maximal effort 10)
Week 5
RPE
Time Frame: Week 10
10-point scale (no exertion 0- maximal effort 10)
Week 10
1 RM
Time Frame: Week 0
Bench press and squats
Week 0
1 RM
Time Frame: Week 5
Bench press and squats
Week 5
1 RM
Time Frame: Week 10
Bench press and squats
Week 10
Parameters determined by ENCODER
Time Frame: Week 0
Bench press and squats
Week 0
Parameters determined by ENCODER
Time Frame: Week 5
Bench press and squats
Week 5
Parameters determined by ENCODER
Time Frame: Week 10
Bench press and squats
Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Europea de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIPI/20/209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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