Effect of Vitamin D and Branched-chain Amino Acids on Physical Performance and Biomarkers of Muscle Fatigue in Runners
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Training program, Branched-Chain Amino Acids, Vitamin D, Placebo 1.
- Who it may be relevant to
- Registry conditions: Healthy Adult Male, Runners. Basic parameters: 25 years — 44 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Other Training program
Aerobic training program (60-90% of maximum aerobic speed) - Dietary supplement Branched-Chain Amino Acids
Branched-chain amino acids (5 gr/day) - Dietary supplement Vitamin D
Vitamin D (1000 IU/day) - Other Placebo 1
Placebo 1 (5gr/day) - Other Placebo 2
Placebo 2 (1 tablet/day)
Primary outcome measures
- Changes in lactate levels compared to the placebo group [Time frame: 8 weeks]
- Changes in interleukin-6 levels compared to the placebo group [Time frame: 8 weeks]
- Changes in cratine kinase levels compared to the placebo group [Time frame: 8 weeks]
- Changes in testosterone cortisol ratio compared to the placebo group [Time frame: 8 weeks]
- Changes in maximal aerobic speed compared to the placebo group [Time frame: 8 weeks]
- Changes in maximal oxygen consumption compared to the placebo group [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Mexico · 1 center
- Universidad de Colima — Colima
Publications
- 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
- 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
Identifiers
NCT: NCT07334054 · 2025-15b