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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07334054
Enrollment
64
Registered
2026-01-12
Start date
2026-01-01
Completion date
2026-06-01
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Male, Runners

Brief summary

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.

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.

Interventions

OTHERTraining program

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

DIETARY_SUPPLEMENTBranched-Chain Amino Acids

Branched-chain amino acids (5 gr/day)

DIETARY_SUPPLEMENTVitamin D

Vitamin D (1000 IU/day)

OTHERPlacebo 1

Placebo 1 (5gr/day)

OTHERPlacebo 2

Placebo 2 (1 tablet/day)

Sponsors

Claudia Ivette Gamboa Gomez
CollaboratorUNKNOWN
Fabian Rojas Larios
CollaboratorUNKNOWN
Pedro Julian Flores Moreno
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

The research is categorized as double-blind parallel groups, the study subjects will be blinded, by not recognizing that they are under supplementation and secondly the principal investigator will also be unaware of the assigned treatment.

Intervention model description

In clinical trial types based on their methodology, this protocol is considered a randomized controlled clinical trial. Based on the behavior of its groups, the research is categorized as a parallel group.

Eligibility

Sex/Gender
MALE
Age
25 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in lactate levels compared to the placebo group8 weeksmMol/L
Changes in interleukin-6 levels compared to the placebo group8 weekspg/ml
Changes in cratine kinase levels compared to the placebo group8 weeksU/L
Changes in testosterone cortisol ratio compared to the placebo group8 weeksmcg/dL
Changes in maximal aerobic speed compared to the placebo group8 weekskm/h
Changes in maximal oxygen consumption compared to the placebo group8 weeksml.O2.kg/min

Countries

Mexico

Contacts

Primary ContactMaría Zepeda Fuentes, Master of Medical Sciences
mzepeda6@ucol.mx523121538794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026