Effects of Vitamin B12 and Natural Orange Extract, and Their Combination on Physical and Mental Performance

NCT07341789 | Enrolling By Invitation

• 1 other identifier: CE092504
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effects of a new formulation of vitamin B12, natural orange extract, and their combination on physical and mental performance.

Conditions

Vitamin b12; Supplementation During Endurance Performance; Flavonoids; Mental Fatigue; Biomarker Feedback

Keywords

Ergogenic aids; Wingate test; Vitamin B12; Polyphenols; Performance; Natural orange extract

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 4 weeks

Secondary Outcomes (11)

• Mental fatigue test

  Throughout study completion, an average of 4 weeks

• Hematological Parameters

  Throughout study completion, an average of 4 weeks

• Iron Status Marker

  Throughout study completion, an average of 4 weeks

• Vitamin B12 Status - Serum Vitamin B12

  Throughout study completion, an average of 4 weeks

• Functional Vitamin B12 Biomarkers

  Throughout study completion, an average of 4 weeks

Study Arms (4)

Vitamin B12

EXPERIMENTAL

This group will take 1.0 mg of vitamin B12 two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total.

Dietary Supplement: Vitamin B 12

Natural orange extract

EXPERIMENTAL

This group will take 500 mg of natural orange extract two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total.

Dietary Supplement: Natural orange extract

Vitamin B12 + natural orange extract

EXPERIMENTAL

This group will take 1.0 mg of vitamin B12 + 500 mg of natural orange extract two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total.

Combination Product: Vitamina B12 + natural orange extract

Placebo

PLACEBO COMPARATOR

This group will take 500 mg of microcrystalline cellulose two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total.

Dietary Supplement: Microcrystalline Cellulose

Interventions

Vitamin B 12 DIETARY_SUPPLEMENT

Subjects in this group will intake 1 mg/day of vitamin B12.

Also known as: Vitamin B12

Vitamin B12

Natural orange extract DIETARY_SUPPLEMENT

Subjects in this groups will intake 500 mg/day of natural orange extract.

Natural orange extract

Vitamina B12 + natural orange extract COMBINATION_PRODUCT

This group will take the combination of vitamin B12 and Vitamina B12 (1 mg/day) + natural orange extract (500 mg/day).

Vitamin B12 + natural orange extract

Microcrystalline Cellulose DIETARY_SUPPLEMENT

Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy male (to be certified through medical examination and health analysis).
• Aged 18-45 years.
• Well-trained (3-6 training sessions per week).
• Habitual consumer of citrus fruits (orange, mandarin, lemon, or grapefruit, either fresh or juiced).

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

Study Sites (1)

Research Center for High Performance Sport. Universidad Católica de Murcia

La Ñora, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Mental Fatigue

Interventions

Vitamin B 12; microcrystalline cellulose

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 Martinez Noguera, PhD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The company that formulated the supplements and placebo carried out the randomization, so no one on the research team or among the sponsors knew which group each study subject belonged to. The results of the randomization were sent to our laboratory after the study was completed to determine which subjects were in each group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: A triple-blind, randomized, crossover clinical trial will be conducted with three experimental groups (vitamin B12 + natural orange extract; natural orange extract; and vitamin B12) and one placebo group (microcrystalline cellulose). Acute effects will be evaluated after a loading phase (three intakes, one per day including the test day). A 7-day washout period will be implemented between interventions.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 14, 2026
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)