HypertrophyNCT04828642
Antioxidant Vitaminas and Hypertrophy Adaptations to Resistance Training
A study testing Vitamin C and vitamin E in people with Hypertrophy, run by Universidad Europea de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy
- What is being tested?
- Vitamin C and vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Experience in strength training of at least one year
Who cannot join
- Smokers
- Antioxidant supplementation
- Injuries or diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertrophy
- Being tested
- Vitamin C and vitamin E, Placebo
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C and vitamin EDietary supplement
Also called Ascorbic acid and tocopherol
1000 mg 235 mg
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Supplementation group | Active comparator | Antioxidant vitamins (Vitamin C (1000 mg) + Vitamine E (235 mg)) Receives: Dietary Supplement: Vitamin C and vitamin E |
| Placebo group | Placebo comparator | Placebo supplementation with the same aspect as supplementation Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEXA
Evaluation of muscle mass with dual energy X-ray absorptiometry
Measured: Week 0
DEXA
Evaluation of muscle mass with dual energy X-ray absorptiometry
Measured: Week 10
Anthropometry
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Measured: Week 0
Anthropometry
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Measured: Week 5
Anthropometry
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Measured: Week 10
Bioimpedance
Evaluation of muscle mass with an Inbody
Measured: Week 0
Bioimpedance
Evaluation of muscle mass with an Inbody
Measured: Week 5
Bioimpedance
Evaluation of muscle mass with an Inbody
Measured: Week10
DOMS
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Measured: Week 0
DOMS
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Measured: Week 5
DOMS
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Measured: Week 10
Manual dinamometry
Handgrip
Measured: Week 0
Manual dinamometry
Handgrip
Measured: Week 5
Leg dinamometry
Dinamometer
Measured: Week 0
Leg dinamometry
Dinamometer
Measured: Week 5
Leg dinamometry
Dinamometer
Measured: Week 10
RPE
10-point scale (no exertion 0- maximal effort 10)
Measured: Week 0
RPE
10-point scale (no exertion 0- maximal effort 10)
Measured: Week 5
RPE
10-point scale (no exertion 0- maximal effort 10)
Measured: Week 10
1 RM
Bench press and squats
Measured: Week 0
1 RM
Bench press and squats
Measured: Week 5
1 RM
Bench press and squats
Measured: Week 10
Parameters determined by ENCODER
Bench press and squats
Measured: Week 0
Parameters determined by ENCODER
Bench press and squats
Measured: Week 5
Parameters determined by ENCODER
Bench press and squats
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Feb 2021
- Primary completion15 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-control, parallel controlled trial will be conducted.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Martínez Ferrán, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828642
- Sponsor's protocol ID
- CIPI/20/209
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31970196Dutra 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.
PubMed 29939770
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamins C and Vitamin E and Hypertrophy Adaptations to Resistance Traini
- ClinicalTrials.gov ID
- NCT04828642
- Acronym / sponsor ID
- CIPI/20/209
- Conditions
- Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-control, parallel controlled trial will be conducted.
| Arm | Type | Receives |
|---|---|---|
| Supplementation group | Active comparator | Dietary Supplement: Vitamin C and vitamin EAntioxidant vitamins (Vitamin C (1000 mg) + Vitamine E (235 mg)) |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplementation with the same aspect as supplementation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Experience in strength training of at least one year
Key exclusion criteria (3 listed)
- Smokers
- Antioxidant supplementation
- Injuries or diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C and vitamin EAlso: Ascorbic acid and tocopherol1000 mg 235 mg | Dietary supplement | Supplementation group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
DEXA
Time frame: Week 0
Evaluation of muscle mass with dual energy X-ray absorptiometry
DEXA
Time frame: Week 10
Evaluation of muscle mass with dual energy X-ray absorptiometry
Anthropometry
Time frame: Week 0
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Anthropometry
Time frame: Week 5
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Anthropometry
Time frame: Week 10
Evaluation of muscle mass by a ISAK 1 level anthropometrist
Bioimpedance
Time frame: Week 0
Evaluation of muscle mass with an Inbody
Bioimpedance
Time frame: Week 5
Evaluation of muscle mass with an Inbody
Bioimpedance
Time frame: Week10
Evaluation of muscle mass with an Inbody
DOMS
Time frame: Week 0
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
DOMS
Time frame: Week 5
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
DOMS
Time frame: Week 10
Delayed onset muscle soreness evaluated with visual analoguic scale (0 no pain- 10 maximal pain)
Manual dinamometry
Time frame: Week 0
Handgrip
Manual dinamometry
Time frame: Week 5
Handgrip
Leg dinamometry
Time frame: Week 0
Dinamometer
Leg dinamometry
Time frame: Week 5
Dinamometer
Leg dinamometry
Time frame: Week 10
Dinamometer
RPE
Time frame: Week 0
10-point scale (no exertion 0- maximal effort 10)
RPE
Time frame: Week 5
10-point scale (no exertion 0- maximal effort 10)
RPE
Time frame: Week 10
10-point scale (no exertion 0- maximal effort 10)
1 RM
Time frame: Week 0
Bench press and squats
1 RM
Time frame: Week 5
Bench press and squats
1 RM
Time frame: Week 10
Bench press and squats
Parameters determined by ENCODER
Time frame: Week 0
Bench press and squats
Parameters determined by ENCODER
Time frame: Week 5
Bench press and squats
Parameters determined by ENCODER
Time frame: Week 10
Bench press and squats
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 31970196Dutra 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 publication: PubMed 29939770Dutra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C and vitamin E in people with Hypertrophy, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEXA (time frame: Week 0). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828642, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.