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NCT Number: NCT07334054

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

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.

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Key information

Conditions

Healthy Adult Male Runners

Age range

25 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Colima

Colima, 28040, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training program

Other

Aerobic training program (60-90% of maximum aerobic speed)

Other names: TP

Branched-chain amino acids

Dietary Supplement

Branched-chain amino acids (5 gr/day)

Other names: BCAA

Vitamin D

Dietary Supplement

Vitamin D (1000 IU/day)

Other names: VitD

Placebo 1

Other

Placebo 1 (5gr/day)

Other names: P1

Placebo 2

Other

Placebo 2 (1 tablet/day)

Other names: P2

Primary outcomes

  1. Changes in lactate levels compared to the placebo group

    Time frame: 8 weeks

    mMol/L

  2. Changes in interleukin-6 levels compared to the placebo group

    Time frame: 8 weeks

    pg/ml

  3. Changes in cratine kinase levels compared to the placebo group

    Time frame: 8 weeks

    U/L

  4. Changes in testosterone cortisol ratio compared to the placebo group

    Time frame: 8 weeks

    mcg/dL

  5. Changes in maximal aerobic speed compared to the placebo group

    Time frame: 8 weeks

    km/h

  6. Changes in maximal oxygen consumption compared to the placebo group

    Time frame: 8 weeks

    ml.O2.kg/min

Study contacts

Contact information is provided by the study sponsor or research team.

María Zepeda Fuentes, Master of Medical Sciences

CONTACT

[email protected]

523121538794

Sponsors and collaborators

Lead sponsor

Pedro Julian Flores Moreno

Other

Collaborators

  • Claudia Ivette Gamboa Gomez
  • Fabian Rojas Larios

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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