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

NCT07334054 | Not Yet Recruiting

• 1 other identifier: 2025-15b
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Male; Runners

Outcome Measures

Primary Outcomes (6)

• Changes in lactate levels compared to the placebo group

  mMol/L

  8 weeks

• Changes in interleukin-6 levels compared to the placebo group

  pg/ml

  8 weeks

• Changes in cratine kinase levels compared to the placebo group

  U/L

  8 weeks

• Changes in testosterone cortisol ratio compared to the placebo group

  mcg/dL

  8 weeks

• Changes in maximal aerobic speed compared to the placebo group

  km/h

  8 weeks

• Changes in maximal oxygen consumption compared to the placebo group

  ml.O2.kg/min

  8 weeks

Study Arms (4)

Group 1 (TP + BCAA + VitD)

EXPERIMENTAL

Training Program + Branched-Chain Amino Acids + Vitamin D

Other: Training program; Dietary Supplement: Branched-Chain Amino Acids; Dietary Supplement: Vitamin D

Group 2 (TP + BCAA + P2)

EXPERIMENTAL

Training Program + Branched-Chain Amino Acids + Placebo 2

Other: Training program; Dietary Supplement: Branched-Chain Amino Acids; Other: Placebo 2

Group 3 (TP + VitD + P1)

EXPERIMENTAL

Training Program + Vitamin D (1000 IU) + Placebo 1

Other: Training program; Dietary Supplement: Vitamin D; Other: Placebo 1

Group 4 (TP + P1+ P2)

PLACEBO COMPARATOR

Training Program + Placebo1 + Placebo 2

Other: Training program; Other: Placebo 1; Other: Placebo 2

Interventions

Vitamin D DIETARY_SUPPLEMENT

Vitamin D (1000 IU/day)

Also known as: VitD

Group 1 (TP + BCAA + VitD); Group 3 (TP + VitD + P1)

Training program OTHER

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

Also known as: TP

Group 1 (TP + BCAA + VitD); Group 2 (TP + BCAA + P2); Group 3 (TP + VitD + P1); Group 4 (TP + P1+ P2)

Branched-Chain Amino Acids DIETARY_SUPPLEMENT

Branched-chain amino acids (5 gr/day)

Also known as: BCAA

Group 1 (TP + BCAA + VitD); Group 2 (TP + BCAA + P2)

Placebo 1 OTHER

Placebo 1 (5gr/day)

Also known as: P1

Group 3 (TP + VitD + P1); Group 4 (TP + P1+ P2)

Placebo 2 OTHER

Placebo 2 (1 tablet/day)

Also known as: P2

Group 2 (TP + BCAA + P2); Group 4 (TP + P1+ P2)

Eligibility Criteria

• Age: 25 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pedro Julian Flores Moreno: lead
• Claudia Ivette Gamboa Gomez: collaborator
• Fabian Rojas Larios: collaborator

Study Sites (1)

Universidad de Colima

Colima, Colima, 28040, Mexico

Location

Related Publications (2)

• Howatson G, Hoad M, Goodall S, Tallent J, Bell PG, French DN. Exercise-induced muscle damage is reduced in resistance-trained males by branched chain amino acids: a randomized, double-blind, placebo controlled study. J Int Soc Sports Nutr. 2012 Jul 12;9:20. doi: 10.1186/1550-2783-9-20. eCollection 2012.

  PMID: 22569039 BACKGROUND

• Zebrowska A, Sadowska-Krepa E, Stanula A, Waskiewicz Z, Lakomy O, Bezuglov E, Nikolaidis PT, Rosemann T, Knechtle B. The effect of vitamin D supplementation on serum total 25(OH) levels and biochemical markers of skeletal muscles in runners. J Int Soc Sports Nutr. 2020 Apr 9;17(1):18. doi: 10.1186/s12970-020-00347-8.

  PMID: 32272973 BACKGROUND

MeSH Terms

Interventions

Amino Acids, Branched-Chain; Vitamin D; P-2

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Pedro J Flores Moreno, Doctor of Medical Sciences

  Universidad de Colima

  STUDY DIRECTOR

Central Study Contacts

María Zepeda Fuentes, Master of Medical Sciences

CONTACT

523121538794; mzepeda6@ucol.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Medical Sciences

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion: March 30, 2026
• Study Completion: June 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ME (1)