Effect of a New Formulation of Vitamin B12 on Physical and Mental

NCT06639789 | Recruiting

• 1 other identifier: CE052416
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Performance Enhancing Product Use

Keywords

Anaerobic performance; Power; Mental fatigue; Vitamins; Recovery

Outcome Measures

Primary Outcomes (1)

• Wingate test

  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 Outcomes (3)

• Mental fatigue test

  Throughout study completion, an average of 3 weeks

• Biochemical markers

  Throughout study completion, an average of 3 weeks

• Sleep Quality Questionnaire (Pittsburgh)

  Throughout study completion, an average of 3 weeks

Study Arms (2)

Vitamin B12 (B12)

EXPERIMENTAL

Subjects in this group will intake 1 mg/day of vitamin B12 three days before the tests.

Dietary Supplement: Vitamin B12 (B12)

PLACEBO (PLA)

PLACEBO COMPARATOR

Subjects in this group will intake 200 mg/day of microcrystalline cellulose three days before the tests.

Dietary Supplement: PLACEBO (PLA)

Interventions

Vitamin B12 (B12) DIETARY_SUPPLEMENT

The new formulation of vitamin B12 will be ingested 3 days before and on the day of testing (3 hours before).

Vitamin B12 (B12)

PLACEBO (PLA) DIETARY_SUPPLEMENT

The placebo will be ingested 3 days before and the same day of the tests (3 hours before).

PLACEBO (PLA)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Javier Martínez Noguera: lead
• Universidad Católica San Antonio de Murcia: collaborator

Study Sites (1)

Research Center for High Performance Sport. Catholic University of Murcia

La Ñora, Murcia, 30830, Spain

RECRUITING

MeSH Terms

Conditions

Mental Fatigue

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Francisco Javier J Martínez Noguera

  Research Center for High Performance Sport. Catholic University of Murcia

  STUDY CHAIR

Central Study Contacts

Francisco Javier FJ Martínez Noguera, PhD

CONTACT

(+34) 968278566; fjmartinez3@ucam.edu

Cristian C Marín Pagán, PhD

CONTACT

(+34) 968278566; cmarin@ucam.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD (Head of the nutrition area of the Research Center for High Performance Sport)

Model Details: A randomized crossover study will be conducted in which 18 subjects will perform the following conditions: B12) 1 mg/d vitamin B12; PLA) 200 mg/d placebo (microcrystalline cellulose) 3 days before physical and cognitive performance tests.

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: October 15, 2024
• Study Start: July 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

ES (1)