Oxidative StressAntioxidantNCT05127928
Antioxidants Vitamins and Muscle Damage
A study testing Dietary Supplement: Vitamin C and vitamin E in people with Oxidative Stress, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Determine if acute supplementation with antioxidant vitamins (vitamin C and vitamin E) influences the muscle damage and fatigue caused after an acute session of eccentric training. Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Dietary Supplement: Vitamin C and vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2022to 6 Mar 2022
- 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 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Physically active
Who cannot join
- Injuries
- Supplementation or drugs
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Determine if acute supplementation with antioxidant vitamins (vitamin C and vitamin E) influences the muscle damage and fatigue caused after an acute session of eccentric training.
Read the detailed description
A randomized, single-blind, placebo-control parallel trial will be conducted. In a previous session volunteers will be interviewed to determine if they meet the inclusion criteria.
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. Participants will be divided in to groups and will performance one resistance exercise sessions. Prior to exercise, one group will intake supplementation VitC (1000 mg) + VitE (235 mg) and the other supplementation with placebo.
The following sequence will be performed in each session: 1) baseline assessment (analysis of the composition body, blood draw and parameters of performance) prior to exercise session ; 2) administration of vitamin or placebo supplementation 2 hours before exercise session ; 3) post-exercise assessments (blood biomarkers and performance parameters) immediately after the session and after 24 hours. DOMS will also be assessed 48 h and 72 h after training. The training session implemented will be designed by a Sport Scientific
- Conditions
- Oxidative Stress
- Being tested
- Dietary Supplement: Vitamin C and vitamin E, Placebo
- Keywords
- antioxidant vitamins, oxidative damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Vitamin C and vitamin EDietary supplement
Also called Ascorbic acid and tocopherol
Antioxidant supplementation
PlaceboDietary supplement
Placebo administration
| Study group | Role | What they receive |
|---|---|---|
| Supplementation | Experimental | Vitamin C and Vitamin E before exercise Receives: Dietary Supplement: Dietary Supplement: Vitamin C and vitamin E |
| Placebo | Placebo comparator | Placebo before exercise Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of body fat and muscle mass
Determination of body composition using skinfolds measurements
Measured: Prior to the intervention
DOMS
Delayed onset muscle soreness. This outcome will be measure with a 10-point visual analogic scale (0= no pain; 10 = worst possible pain)
Measured: 0 hours post exercise
DOMS
Delayed onset muscle soreness. This outcome will be measure with a 10-point visual analogic scale (0= no pain; 10 = worst possible pain)
Measured: 24 hours post exercise
Blood malondialdehyde (MDA)
MDA will be analyzed from a blood sample
Measured: 2 hours prior to exercise
Blood creatine quinase (CK)
CK will be analyzed from a blood sample
Measured: 2 hours prior to exercise
Blood malondialdehyde (MDA)
MDA will be analyzed from a blood sample
Measured: Inmediatly after exercise
Blood malondialdehyde (MDA)
MDA will be analyzed from a blood sample
Measured: 24 hours after exercise
Blood creatine quinase (CK)
CK will be analyzed from a blood sample
Measured: 24 hours after exercise
Jump height in a Counter Movement Jump
Jump height (cm) in a counter movement jump measured with Octojump Platform
Measured: 2 hours prior to exercise
Jump height in a Counter Movement Jump
Jump height (cm) in a counter movement jump measured with Octojump Platform
Measured: Inmediatly after exercise
Jump height in a Counter Movement Jump
Jump height (cm) in a counter movement jump measured with Octojump Platform
Measured: 24 h after exercise
Jump Height in a Squat Jump
Jump Height (cm) in a Squat Jump measured with Octojump Platform
Measured: 24 h after exercise
Jump Height in a Squat Jump
Jump Height (cm) in a Squat Jump measured with Octojump Platform
Measured: Inmediately after exercise
Jump Height in a squat Jump
Jump height (cm) in a squat jump with Octojump Platform measured with Octojump Platform
Measured: 2 hours prior to exercise
Jump Height in a Drop Jump
Jump height (cm) was measured in different drop jumps with Octojump Platform
Measured: 2 hours prior to exercise
Jump Height in a Drop Jump
Jump height (cm) was measured in different drop jumps with Octojump Platform
Measured: Inmediately after exercise
Contact time in a Drop Jump
Contact time (s)measured in different drop jumps with Octojump Platform
Measured: Inmediately after exercise
Jump Height in a Drop Jump
Jump height (cm) measured in different drop jumps with Octojump Platform
Measured: Inmediately after exercise
Contact time in a Drop Jump
Contact time (s) measured in different drop jumps with Octojump Platform
Measured: 24 hours after exercise
Jump Height in a Drop Jump
Jump height (cm) measured in different drop jumps with Octojump Platform
Measured: 24 hours after exercise
Contact time in a Drop Jump
Capillary blood lactate evaluated with Lactate Pro 2
Measured: Inmediately after exercise
Concentration of blood lactate
Capillary blood lactate with Lactate Pro 2
Measured: 2 hours before exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 Feb 2022
- Primary completion15 Feb 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 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
- NCT05127928
- Sponsor's protocol ID
- CIPI/20/209-part2
- Acronym
- Antioxidant
- Status last verified
- Apr 2022
- First submitted
- 15 Jun 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidants Vitamins and Muscle Damage
- ClinicalTrials.gov ID
- NCT05127928
- Acronym / sponsor ID
- Antioxidant / CIPI/20/209-part2
- Conditions
- Oxidative Stress
- Keywords
- antioxidant vitamins, oxidative damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 19 Nov 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.
Determine if acute supplementation with antioxidant vitamins (vitamin C and vitamin E) influences the muscle damage and fatigue caused after an acute session of eccentric training.
Detailed description
A randomized, single-blind, placebo-control parallel trial will be conducted. In a previous session volunteers will be interviewed to determine if they meet the inclusion criteria.
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. Participants will be divided in to groups and will performance one resistance exercise sessions. Prior to exercise, one group will intake supplementation VitC (1000 mg) + VitE (235 mg) and the other supplementation with placebo.
The following sequence will be performed in each session: 1) baseline assessment (analysis of the composition body, blood draw and parameters of performance) prior to exercise session ; 2) administration of vitamin or placebo supplementation 2 hours before exercise session ; 3) post-exercise assessments (blood biomarkers and performance parameters) immediately after the session and after 24 hours. DOMS will also be assessed 48 h and 72 h after training. The training session implemented will be designed by a Sport Scientific
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementation | Experimental | Dietary Supplement: Dietary Supplement: Vitamin C and vitamin EVitamin C and Vitamin E before exercise |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo before exercise |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Physically active
Key exclusion criteria (3 listed)
- Injuries
- Supplementation or drugs
- Smokers
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 |
|---|---|---|
| Dietary Supplement: Vitamin C and vitamin EAlso: Ascorbic acid and tocopherolAntioxidant supplementation | Dietary supplement | Supplementation |
| PlaceboPlacebo administration | Dietary supplement | Placebo |
Primary outcome
Percentage of body fat and muscle mass
Time frame: Prior to the intervention
Determination of body composition using skinfolds measurements
DOMS
Time frame: 0 hours post exercise
Delayed onset muscle soreness. This outcome will be measure with a 10-point visual analogic scale (0= no pain; 10 = worst possible pain)
DOMS
Time frame: 24 hours post exercise
Delayed onset muscle soreness. This outcome will be measure with a 10-point visual analogic scale (0= no pain; 10 = worst possible pain)
Blood malondialdehyde (MDA)
Time frame: 2 hours prior to exercise
MDA will be analyzed from a blood sample
Blood creatine quinase (CK)
Time frame: 2 hours prior to exercise
CK will be analyzed from a blood sample
Blood malondialdehyde (MDA)
Time frame: Inmediatly after exercise
MDA will be analyzed from a blood sample
Blood malondialdehyde (MDA)
Time frame: 24 hours after exercise
MDA will be analyzed from a blood sample
Blood creatine quinase (CK)
Time frame: 24 hours after exercise
CK will be analyzed from a blood sample
Jump height in a Counter Movement Jump
Time frame: 2 hours prior to exercise
Jump height (cm) in a counter movement jump measured with Octojump Platform
Jump height in a Counter Movement Jump
Time frame: Inmediatly after exercise
Jump height (cm) in a counter movement jump measured with Octojump Platform
Jump height in a Counter Movement Jump
Time frame: 24 h after exercise
Jump height (cm) in a counter movement jump measured with Octojump Platform
Jump Height in a Squat Jump
Time frame: 24 h after exercise
Jump Height (cm) in a Squat Jump measured with Octojump Platform
Jump Height in a Squat Jump
Time frame: Inmediately after exercise
Jump Height (cm) in a Squat Jump measured with Octojump Platform
Jump Height in a squat Jump
Time frame: 2 hours prior to exercise
Jump height (cm) in a squat jump with Octojump Platform measured with Octojump Platform
Jump Height in a Drop Jump
Time frame: 2 hours prior to exercise
Jump height (cm) was measured in different drop jumps with Octojump Platform
Jump Height in a Drop Jump
Time frame: Inmediately after exercise
Jump height (cm) was measured in different drop jumps with Octojump Platform
Contact time in a Drop Jump
Time frame: Inmediately after exercise
Contact time (s)measured in different drop jumps with Octojump Platform
Jump Height in a Drop Jump
Time frame: Inmediately after exercise
Jump height (cm) measured in different drop jumps with Octojump Platform
Contact time in a Drop Jump
Time frame: 24 hours after exercise
Contact time (s) measured in different drop jumps with Octojump Platform
Jump Height in a Drop Jump
Time frame: 24 hours after exercise
Jump height (cm) measured in different drop jumps with Octojump Platform
Contact time in a Drop Jump
Time frame: Inmediately after exercise
Capillary blood lactate evaluated with Lactate Pro 2
Concentration of blood lactate
Time frame: 2 hours before exercise
Capillary blood lactate with Lactate Pro 2
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 7 Apr 2022.
- 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 Dietary Supplement: Vitamin C and vitamin E in people with Oxidative Stress, 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 2 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 7 Apr 2022. 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?
Percentage of body fat and muscle mass (time frame: Prior to the intervention). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2022.