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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

64

Phase

  • 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

  • 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

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
Intervention / Treatment
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

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

Pedro Julian Flores Moreno

Collaborators

Fabian Rojas Larios
Claudia Ivette Gamboa Gomez

Investigators

  • 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)

January 1, 2026

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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