- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05127928
Antioxidants Vitamins and Muscle Damage (Antioxidant)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain
- Universidad Europea de Madrid
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
- Physically active
Exclusion Criteria:
- Injuries
- Supplementation or drugs
- Smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supplementation
Vitamin C and Vitamin E before exercise
|
Antioxidant supplementation
Other Names:
|
|
Placebo Comparator: Placebo
Placebo before exercise
|
Placebo administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of body fat and muscle mass
Time Frame: Prior to the intervention
|
Determination of body composition using skinfolds measurements
|
Prior to the intervention
|
|
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)
|
0 hours post exercise
|
|
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)
|
24 hours post exercise
|
|
Blood malondialdehyde (MDA)
Time Frame: 2 hours prior to exercise
|
MDA will be analyzed from a blood sample
|
2 hours prior to exercise
|
|
Blood creatine quinase (CK)
Time Frame: 2 hours prior to exercise
|
CK will be analyzed from a blood sample
|
2 hours prior to exercise
|
|
Blood malondialdehyde (MDA)
Time Frame: Inmediatly after exercise
|
MDA will be analyzed from a blood sample
|
Inmediatly after exercise
|
|
Blood malondialdehyde (MDA)
Time Frame: 24 hours after exercise
|
MDA will be analyzed from a blood sample
|
24 hours after exercise
|
|
Blood creatine quinase (CK)
Time Frame: 24 hours after exercise
|
CK will be analyzed from a blood sample
|
24 hours after exercise
|
|
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
|
2 hours prior to exercise
|
|
Jump height in a Counter Movement Jump
Time Frame: Inmediatly after exercise
|
Jump height (cm) in a counter movement jump measured with Octojump Platform
|
Inmediatly after exercise
|
|
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
|
24 h after exercise
|
|
Jump Height in a Squat Jump
Time Frame: 24 h after exercise
|
Jump Height (cm) in a Squat Jump measured with Octojump Platform
|
24 h after exercise
|
|
Jump Height in a Squat Jump
Time Frame: Inmediately after exercise
|
Jump Height (cm) in a Squat Jump measured with Octojump Platform
|
Inmediately after exercise
|
|
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
|
2 hours prior to exercise
|
|
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
|
2 hours prior to exercise
|
|
Jump Height in a Drop Jump
Time Frame: Inmediately after exercise
|
Jump height (cm) was measured in different drop jumps with Octojump Platform
|
Inmediately after exercise
|
|
Contact time in a Drop Jump
Time Frame: Inmediately after exercise
|
Contact time (s)measured in different drop jumps with Octojump Platform
|
Inmediately after exercise
|
|
Jump Height in a Drop Jump
Time Frame: Inmediately after exercise
|
Jump height (cm) measured in different drop jumps with Octojump Platform
|
Inmediately after exercise
|
|
Contact time in a Drop Jump
Time Frame: 24 hours after exercise
|
Contact time (s) measured in different drop jumps with Octojump Platform
|
24 hours after exercise
|
|
Jump Height in a Drop Jump
Time Frame: 24 hours after exercise
|
Jump height (cm) measured in different drop jumps with Octojump Platform
|
24 hours after exercise
|
|
Contact time in a Drop Jump
Time Frame: Inmediately after exercise
|
Capillary blood lactate evaluated with Lactate Pro 2
|
Inmediately after exercise
|
|
Concentration of blood lactate
Time Frame: 2 hours before exercise
|
Capillary blood lactate with Lactate Pro 2
|
2 hours before exercise
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIPI/20/209-part2
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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