- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04828642
Antioxidant Vitaminas and Hypertrophy Adaptations to Resistance Training
Vitamins C and Vitamin E and Hypertrophy Adaptations to Resistance Traini
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28011
- Universidad Europea de Madrid
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Experience in strength training of at least one year
Exclusion Criteria:
- Smokers
- Antioxidant supplementation
- Injuries or diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Supplementation group
Antioxidant vitamins (Vitamin C (1000 mg) + Vitamine E (235 mg))
|
1000 mg 235 mg
Other Names:
|
PLACEBO_COMPARATOR: Placebo group
Placebo supplementation with the same aspect as supplementation
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIPI/20/209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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