Effect of Vitamin D and Branched-chain Amino Acids on Physical Performance and Biomarkers of Muscle Fatigue in Runners

January 5, 2026 updated by: Pedro Julian Flores Moreno

Effect of Vitamin D and Branched-chain Amino Acids on Physical Performance and Biomarkers of Muscle Fatigue in Runners: an 8-week Randomized, Double-blind

Muscle fatigue caused by physical training is understood as a condition related to the inability to maintain action potential, derived from the alteration in skeletal muscle homeostasis. In long-distance recreational runners, prolonged physical work is performed while maintaining the level of intensity, where a level of fatigue intervenes, which overlaps and generates tiredness to execute the movement continuously. In the last 10 years, sports supplementation has been explored as an aid to increase physical performance, improve muscle recovery and prevent sports injuries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective:

To analyze the effects of an 8-week training program (TP) with vitamin D and branched-chain amino acids (BCAA) supplementation on physical performance and biomarkers of muscle fatigue in long-distance recreational runners.

Materials and methods:

An 8-week randomized controlled clinical trial. Participants will be 64 men aged 25 to 44 years, distributed into 4 intervention groups. Group A: Training + BCAA + Vitamin D. Group B: Training + BCAA + Placebo. Group C: Training + Vitamin D + Placebo. Group D: Training + Placebo + Placebo. Biomarkers of muscle fatigue Interleukin 6 (L-6), Creatine Kinase (CK), Lactate (Lact), Testosterone and Cortisol ratio and serum vitamin D (25(OH)D) and physical performance will be assessed by estimating Maximal oxygen consumption (VO2max) and (Maximal aerobic speed) MAS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: María Zepeda Fuentes, Master of Medical Sciences
  • Phone Number: 523121538794
  • Email: mzepeda6@ucol.mx

Study Locations

  • Mexico
    • Colima
      • Colima, Colima, Mexico, 28040
        • Universidad de Colima

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 25 to 44
  • Men
  • Agree to participate in the study
  • Sign a consent form
  • Experience in long-distance running

Exclusion Criteria:

  • Have a previous diagnosis of liver disease, asthma, hypertension, diabetes, cancer, anemia
  • Have a previous diagnosis of a neurological disorder (Alzheimer's disease, Parkinson's disease, epilepsy)
  • Have a musculoskeletal disability
  • Be on medication or supplementation
  • Hypervitaminosis D (>100 ng/mL)
  • Be on a structured training program
  • Use anabolic steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 (TP + BCAA + VitD)
Training Program + Branched-Chain Amino Acids + Vitamin D
Other: Training program
Aerobic training program (60-90% of maximum aerobic speed)
Other Names:
  • TP
Dietary supplement: Branched-Chain Amino Acids
Branched-chain amino acids (5 gr/day)
Other Names:
  • BCAA
Dietary supplement: Vitamin D
Vitamin D (1000 IU/day)
Other Names:
  • VitD
Experimental: Group 2 (TP + BCAA + P2)
Training Program + Branched-Chain Amino Acids + Placebo 2
Other: Training program
Aerobic training program (60-90% of maximum aerobic speed)
Other Names:
  • TP
Dietary supplement: Branched-Chain Amino Acids
Branched-chain amino acids (5 gr/day)
Other Names:
  • BCAA
Other: Placebo 2
Placebo 2 (1 tablet/day)
Other Names:
  • P2
Experimental: Group 3 (TP + VitD + P1)
Training Program + Vitamin D (1000 IU) + Placebo 1
Other: Training program
Aerobic training program (60-90% of maximum aerobic speed)
Other Names:
  • TP
Dietary supplement: Vitamin D
Vitamin D (1000 IU/day)
Other Names:
  • VitD
Other: Placebo 1
Placebo 1 (5gr/day)
Other Names:
  • P1
Placebo Comparator: Group 4 (TP + P1+ P2)
Training Program + Placebo1 + Placebo 2
Other: Training program
Aerobic training program (60-90% of maximum aerobic speed)
Other Names:
  • TP
Other: Placebo 2
Placebo 2 (1 tablet/day)
Other Names:
  • P2
Other: Placebo 1
Placebo 1 (5gr/day)
Other Names:
  • P1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in lactate levels compared to the placebo group
Time Frame: 8 weeks
mMol/L
8 weeks
Changes in interleukin-6 levels compared to the placebo group
Time Frame: 8 weeks
pg/ml
8 weeks
Changes in cratine kinase levels compared to the placebo group
Time Frame: 8 weeks
U/L
8 weeks
Changes in testosterone cortisol ratio compared to the placebo group
Time Frame: 8 weeks
mcg/dL
8 weeks
Changes in maximal aerobic speed compared to the placebo group
Time Frame: 8 weeks
km/h
8 weeks
Changes in maximal oxygen consumption compared to the placebo group
Time Frame: 8 weeks
ml.O2.kg/min
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pedro Julian Flores Moreno

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fabian Rojas Larios
Claudia Ivette Gamboa Gomez

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pedro J Flores Moreno, Doctor of Medical Sciences, Universidad de Colima

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-15b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results and analysis will be shared with other researchers collaborating on the research project.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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