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

Pedro Julian Flores Moreno

Status: Not yet enrolling

Conditions: Runners; Healthy Adult Male

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Branched-Chain Amino Acids; Other: Training program; Other: Placebo 2; Other: Placebo 1

Study type: Interventional

Funder types: Other

Identifiers

NCT07334054

2025-15b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: Male

Ages: 25 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

64 participants in 4 patient groups, including a placebo group

Group 1 (TP + BCAA + VitD)

Experimental group

Description:

Training Program + Branched-Chain Amino Acids + Vitamin D

Treatment:

Other: Training program

Dietary Supplement: Branched-Chain Amino Acids

Dietary Supplement: Vitamin D

Group 2 (TP + BCAA + P2)

Experimental group

Description:

Training Program + Branched-Chain Amino Acids + Placebo 2

Treatment:

Other: Placebo 2

Other: Training program

Dietary Supplement: Branched-Chain Amino Acids

Group 3 (TP + VitD + P1)

Experimental group

Description:

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

Treatment:

Other: Placebo 1

Other: Training program

Dietary Supplement: Vitamin D

Group 4 (TP + P1+ P2)

Placebo Comparator group

Description:

Training Program + Placebo1 + Placebo 2

Treatment:

Other: Placebo 1

Other: Placebo 2

Other: Training program