Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639789
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Effect of a New Formulation of Vitamin B12 on Physical and Mental
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effect of a New Formulation of Vitamin B12 on Physical and Mental Performance in Trained Cyclists
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERB12
Brief Summary:
This clinical study evaluates the effect of acute intake of a new vitamin B12 formulation on anaerobic and cognitive performance variables One of the limiting factors for the potential beneficial effects of vitamin B12 is its bioavailability This new formula improves this aspect so that by improving plasma levels of B12 we will be able to relate whether this situation may be related to improved performance or cognitive tasks
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 ReviewEthics 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 75 of each individuals 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
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 ReviewEthics 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 75 of each individuals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None