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Antioxidant Vitaminas and Hypertrophy Adaptations to Resistance Training

Primary Purpose

Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vitamin C and vitamin E
Placebo
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertrophy

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Experience in strength training of at least one year

Exclusion Criteria:

  • Smokers
  • Antioxidant supplementation
  • Injuries or diseases

Sites / Locations

  • Universidad Europea de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Supplementation group

Placebo group

Arm Description

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

Placebo supplementation with the same aspect as supplementation

Outcomes

Primary Outcome Measures

DEXA
Evaluation of muscle mass with dual energy X-ray absorptiometry
DEXA
Evaluation of muscle mass with dual energy X-ray absorptiometry
Anthropometry
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Anthropometry
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Anthropometry
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Bioimpedance
Evaluation of muscle mass with an Inbody
Bioimpedance
Evaluation of muscle mass with an Inbody
Bioimpedance
Evaluation of muscle mass with an Inbody
DOMS
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
DOMS
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
DOMS
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Manual dinamometry
Handgrip
Manual dinamometry
Handgrip
Leg dinamometry
Dinamometer
Leg dinamometry
Dinamometer
Leg dinamometry
Dinamometer
RPE
10-point scale (no exertion 0- maximal effort 10)
RPE
10-point scale (no exertion 0- maximal effort 10)
RPE
10-point scale (no exertion 0- maximal effort 10)
1 RM
Bench press and squats
1 RM
Bench press and squats
1 RM
Bench press and squats
Parameters determined by ENCODER
Bench press and squats
Parameters determined by ENCODER
Bench press and squats
Parameters determined by ENCODER
Bench press and squats

Secondary Outcome Measures

Full Information

First Posted
March 11, 2021
Last Updated
August 1, 2021
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04828642
Brief Title
Antioxidant Vitaminas and Hypertrophy Adaptations to Resistance Training
Official Title
Vitamins C and Vitamin E and Hypertrophy Adaptations to Resistance Traini
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, placebo-control, parallel controlled trial will be conducted.
Masking
ParticipantInvestigator
Masking Description
The provider will produce the supplementation and the placebo with the same aspect, marked with numbers
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplementation group
Arm Type
Active Comparator
Arm Description
Antioxidant vitamins (Vitamin C (1000 mg) + Vitamine E (235 mg))
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo supplementation with the same aspect as supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C and vitamin E
Other Intervention Name(s)
Ascorbic acid and tocopherol
Intervention Description
1000 mg 235 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
DEXA
Description
Evaluation of muscle mass with dual energy X-ray absorptiometry
Time Frame
Week 0
Title
DEXA
Description
Evaluation of muscle mass with dual energy X-ray absorptiometry
Time Frame
Week 10
Title
Anthropometry
Description
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Time Frame
Week 0
Title
Anthropometry
Description
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Time Frame
Week 5
Title
Anthropometry
Description
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Time Frame
Week 10
Title
Bioimpedance
Description
Evaluation of muscle mass with an Inbody
Time Frame
Week 0
Title
Bioimpedance
Description
Evaluation of muscle mass with an Inbody
Time Frame
Week 5
Title
Bioimpedance
Description
Evaluation of muscle mass with an Inbody
Time Frame
Week10
Title
DOMS
Description
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Time Frame
Week 0
Title
DOMS
Description
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Time Frame
Week 5
Title
DOMS
Description
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Time Frame
Week 10
Title
Manual dinamometry
Description
Handgrip
Time Frame
Week 0
Title
Manual dinamometry
Description
Handgrip
Time Frame
Week 5
Title
Leg dinamometry
Description
Dinamometer
Time Frame
Week 0
Title
Leg dinamometry
Description
Dinamometer
Time Frame
Week 5
Title
Leg dinamometry
Description
Dinamometer
Time Frame
Week 10
Title
RPE
Description
10-point scale (no exertion 0- maximal effort 10)
Time Frame
Week 0
Title
RPE
Description
10-point scale (no exertion 0- maximal effort 10)
Time Frame
Week 5
Title
RPE
Description
10-point scale (no exertion 0- maximal effort 10)
Time Frame
Week 10
Title
1 RM
Description
Bench press and squats
Time Frame
Week 0
Title
1 RM
Description
Bench press and squats
Time Frame
Week 5
Title
1 RM
Description
Bench press and squats
Time Frame
Week 10
Title
Parameters determined by ENCODER
Description
Bench press and squats
Time Frame
Week 0
Title
Parameters determined by ENCODER
Description
Bench press and squats
Time Frame
Week 5
Title
Parameters determined by ENCODER
Description
Bench press and squats
Time Frame
Week 10

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Experience in strength training of at least one year Exclusion Criteria: Smokers Antioxidant supplementation Injuries or diseases
Facility Information:
Facility Name
Universidad Europea de Madrid
City
Madrid
ZIP/Postal Code
28011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31970196
Citation
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.
Results Reference
background
PubMed Identifier
29939770
Citation
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.
Results Reference
result

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Antioxidant Vitaminas and Hypertrophy Adaptations to Resistance Training

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