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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04828642
Other study ID # CIPI/20/209
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date June 30, 2021

Study information

Verified date August 2021
Source Universidad Europea de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Experience in strength training of at least one year Exclusion Criteria: - Smokers - Antioxidant supplementation - Injuries or diseases

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin C and vitamin E
1000 mg 235 mg
Placebo
Placebo

Locations

Country Name City State
Spain Universidad Europea de Madrid Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary DEXA Evaluation of muscle mass with dual energy X-ray absorptiometry Week 0
Primary DEXA Evaluation of muscle mass with dual energy X-ray absorptiometry Week 10
Primary Anthropometry Evaluation of muscle mass by a ISAK 1 level anthropometrist Week 0
Primary Anthropometry Evaluation of muscle mass by a ISAK 1 level anthropometrist Week 5
Primary Anthropometry Evaluation of muscle mass by a ISAK 1 level anthropometrist Week 10
Primary Bioimpedance Evaluation of muscle mass with an Inbody Week 0
Primary Bioimpedance Evaluation of muscle mass with an Inbody Week 5
Primary Bioimpedance Evaluation of muscle mass with an Inbody Week10
Primary DOMS Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain) Week 0
Primary DOMS Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain) Week 5
Primary DOMS Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain) Week 10
Primary Manual dinamometry Handgrip Week 0
Primary Manual dinamometry Handgrip Week 5
Primary Leg dinamometry Dinamometer Week 0
Primary Leg dinamometry Dinamometer Week 5
Primary Leg dinamometry Dinamometer Week 10
Primary RPE 10-point scale (no exertion 0- maximal effort 10) Week 0
Primary RPE 10-point scale (no exertion 0- maximal effort 10) Week 5
Primary RPE 10-point scale (no exertion 0- maximal effort 10) Week 10
Primary 1 RM Bench press and squats Week 0
Primary 1 RM Bench press and squats Week 5
Primary 1 RM Bench press and squats Week 10
Primary Parameters determined by ENCODER Bench press and squats Week 0
Primary Parameters determined by ENCODER Bench press and squats Week 5
Primary Parameters determined by ENCODER Bench press and squats Week 10
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