Effect of a New Formulation of Vitamin B12 on Physical and Mental (PERB12)
Evaluation of the Effect of a New Formulation of Vitamin B12 on Physical and Mental Performance in Trained Cyclists.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants
All participants were informed about the procedures and provided signed informed consent. The study was conducted in accordance with the guidelines of the Declaration of Helsinki Declaration for Research Involving Human Subjects and the protocol was approved by the Institutional Review/Ethics Committee of the Catholic University of Murcia (Code: CE052416).
Study design
Randomized, double-blind, placebo-controlled, crossover clinical trial with 2 study groups (vitamin B12 and placebo). Cyclists were instructed to take the supplement (vitamin B12 or placebo) with breakfast on the three days before the tests and 3h before the test day, and to continue with their usual diet and training programme. Subjects in both groups were instructed not to consume vitamin B12-rich foods for 7 days before and during the study. Between each intervention (B12 and Placebo) there was a 7-day washout period.
Procedures
Participants visited the laboratory on three occasions. Visit 1 consisted of a medical examination and a blood draw to determine health status. At visits 2 and 3, a 24-hour diet reminder and a Wingate test, mental fatigue test and venous blood draw were performed. The sports nutritionist prescribed a standardized breakfast before each testing session (visits 2 and 3).
Pre- and post-evaluation test
Visit 1:
Health status blood test: A general blood test will be performed both pre- and post-supplementation. The blood will be drawn through a vein (fasting).
Medical examination: A medical history of family and personal history, an electrocardiogram (ECG) at rest and a medical examination (auscultation, blood pressure, etc.) will be carried out to certify that the person is healthy and does not present a risk to participate in the study (Fasting).
Body composition by absorptiometric densitometry (DXA): A body composition test will be performed using the double energy absorptiometric densitometry technique (X-rays), with the aim of determining parameters of fat mass, fat-free mass and fat percentage. In addition, anthropometry will also be used to determine changes in body composition (fat and muscle mass) (Fasting).
Visits 2 and 3:
Anaerobic power and mechanical power output: After a standardised breakfast, a Wingate test was performed on a cycle ergometer. The Wingate test (WAnT) consisted of a 30 s sprint on a cycle ergometer (Monark Ergomedic 894E Peak Bike, Vansbro, Sweden). Breaking strength was held constant at 7.5% of each individual's body mass. All participants were verbally encouraged to pedal as fast as possible throughout the sprint.
Mental fatigue test: All participants will be tested for the evaluation of reaction time to a sequence of lights set by the investigator before and after the performance test.
Biochemical markers: A venous blood draw will be performed by medical personnel before and after the performance test, in which vitamin B12, creatine kinase and lactate dehydrogenase levels will be analyzed.
All data of the subjects who participated in the study were stored in a computer system with a security key. In addition, some of the data was also recorded on paper and kept under lock and key, accessible only to the researchers of this project.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francisco Javier FJ Martínez Noguera, PhD
- Phone Number: (+34) 968278566
- Email: fjmartinez3@ucam.edu
Study Contact Backup
- Name: Cristian C Marín Pagán, PhD
- Phone Number: (+34) 968278566
- Email: cmarin@ucam.edu
Study Locations
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Murcia
-
La Ñora, Murcia, Spain, 30830
- Recruiting
- Research Center for High Performance Sport. Catholic University of Murcia
-
Contact:
- Francisco Javier Martínez Noguera, PhD
- Phone Number: (+34) 646666782
- Email: fjmartinez3@ucam.edu
-
Contact:
- Cristian Marín Pagán, PhD
- Phone Number: (+34) 968278566
- Email: cmarin@ucam.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male cyclists who have competed in both junior and amateur categories.
- Cycling between 6-15 hours of training per week.
- BMI between 18-25 kg/m2.
Exclusion Criteria:
- Smokers or regular alcohol drinkers.
- Persons suffering from a metabolic, cardiorespiratory or digestive pathology or anomaly.
digestive system.
- People who have suffered an injury in the last 6 months that limits the performance of the study tests. of the study tests.
- People taking supplements or medication in the 2 weeks before the start of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vitamin B12 (B12)
Subjects in this group will intake 1 mg/day of vitamin B12 three days before the tests.
|
The new formulation of vitamin B12 will be ingested 3 days before and on the day of testing (3 hours before).
|
|
Placebo Comparator: PLACEBO (PLA)
Subjects in this group will intake 200 mg/day of microcrystalline cellulose three days before the tests.
|
The placebo will be ingested 3 days before and the same day of the tests (3 hours before).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wingate test
Time Frame: Throughout study completion, an average of 3 weeks
|
This test consists of 5 efforts of 30 seconds at maximum intensity with a recovery of 3 minutes on a bike.
In this test the peak and average power of each effort and the total average will be evaluated.
In addition, the time to maximum peak power and the fatigue index.
|
Throughout study completion, an average of 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental fatigue test
Time Frame: Throughout study completion, an average of 3 weeks
|
In this test, we will measure the speed of reaction in the resolution of a sequence of lights set by the researcher before and after the end of the performance test.
|
Throughout study completion, an average of 3 weeks
|
|
Biochemical markers
Time Frame: Throughout study completion, an average of 3 weeks
|
Vitamin B12, creatine kinase and lactate dehydrogenase concentrations are also measured before and after the performance tests.
|
Throughout study completion, an average of 3 weeks
|
|
Sleep Quality Questionnaire (Pittsburgh)
Time Frame: Throughout study completion, an average of 3 weeks
|
The questionnaire will be carried out 3 days before and one day after the performance tests.
|
Throughout study completion, an average of 3 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Francisco Javier J Martínez Noguera, Research Center for High Performance Sport. Catholic University of Murcia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- CE052416
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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