Healthy Adult MaleNCT07334054
Effect of Vitamin D and Branched-chain Amino Acids on Physical Performance and Biomarkers of Muscle Fatigue in Runners
A study testing Training program, Branched-Chain Amino Acids and Vitamin D in people with Healthy Adult Male and Runners, run by Pedro Julian Flores Moreno at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male, Runners
- What is being tested?
- Training program, Branched-Chain Amino Acids and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 25 to 44
- Men
- Agree to participate in the study
- Sign a consent form
- Experience in long-distance running
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Adult Male, Runners
- Being tested
- Training program, Branched-Chain Amino Acids, Vitamin D, Placebo 1, Placebo 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programOther
Also called TP
Aerobic training program (60-90% of maximum aerobic speed)
Branched-Chain Amino AcidsDietary supplement
Also called BCAA
Branched-chain amino acids (5 gr/day)
Vitamin DDietary supplement
Also called VitD
Vitamin D (1000 IU/day)
Placebo 1Other
Also called P1
Placebo 1 (5gr/day)
Placebo 2Other
Also called P2
Placebo 2 (1 tablet/day)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (TP + BCAA + VitD) | Experimental | Training Program + Branched-Chain Amino Acids + Vitamin D Receives: 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 Receives: 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 Receives: Other: Training program; Dietary Supplement: Vitamin D; Other: Placebo 1 |
| Group 4 (TP + P1+ P2) | Placebo comparator | Training Program + Placebo1 + Placebo 2 Receives: Other: Training program; Other: Placebo 1; Other: Placebo 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lactate levels compared to the placebo group
mMol/L
Measured: 8 weeks
Changes in interleukin-6 levels compared to the placebo group
pg/ml
Measured: 8 weeks
Changes in cratine kinase levels compared to the placebo group
U/L
Measured: 8 weeks
Changes in testosterone cortisol ratio compared to the placebo group
mcg/dL
Measured: 8 weeks
Changes in maximal aerobic speed compared to the placebo group
km/h
Measured: 8 weeks
Changes in maximal oxygen consumption compared to the placebo group
ml.O2.kg/min
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedro Julian Flores Moreno
- Sponsor type
- University, hospital or other
- Collaborators
- Claudia Ivette Gamboa Gomez, Fabian Rojas Larios
- Responsible party
- Sponsor-investigator, Pedro Julian Flores Moreno, Universidad de Colima
- Investigators
- Pedro J Flores Moreno, Doctor of Medical Sciences, Study director, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334054
- Sponsor's protocol ID
- 2025-15b
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results and analysis will be shared with other researchers collaborating on the research project.
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.
PubMed 22569039Zebrowska 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.
PubMed 32272973
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07334054
- Acronym / sponsor ID
- 2025-15b
- Conditions
- Healthy Adult Male, Runners
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Pedro Julian Flores MorenoUniversity, hospital or other
- Collaborators
- Claudia Ivette Gamboa Gomez, Fabian Rojas Larios
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (TP + BCAA + VitD) | Experimental | Other: Training program, Dietary Supplement: Branched-Chain Amino Acids, Dietary Supplement: Vitamin DTraining Program + Branched-Chain Amino Acids + Vitamin D |
| Group 2 (TP + BCAA + P2) | Experimental | Other: Training program, Dietary Supplement: Branched-Chain Amino Acids, Other: Placebo 2Training Program + Branched-Chain Amino Acids + Placebo 2 |
| Group 3 (TP + VitD + P1) | Experimental | Other: Training program, Dietary Supplement: Vitamin D, Other: Placebo 1Training Program + Vitamin D (1000 IU) + Placebo 1 |
| Group 4 (TP + P1+ P2) | Placebo comparator | Other: Training program, Other: Placebo 1, Other: Placebo 2Training Program + Placebo1 + Placebo 2 |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 25 to 44
- Men
- Agree to participate in the study
- Sign a consent form
- Experience in long-distance running
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training programAlso: TPAerobic training program (60-90% of maximum aerobic speed) | Other | Group 1 (TP + BCAA + VitD), Group 2 (TP + BCAA + P2), Group 3 (TP + VitD + P1), Group 4 (TP + P1+ P2) |
| Branched-Chain Amino AcidsAlso: BCAABranched-chain amino acids (5 gr/day) | Dietary supplement | Group 1 (TP + BCAA + VitD), Group 2 (TP + BCAA + P2) |
| Vitamin DAlso: VitDVitamin D (1000 IU/day) | Dietary supplement | Group 1 (TP + BCAA + VitD), Group 3 (TP + VitD + P1) |
| Placebo 1Also: P1Placebo 1 (5gr/day) | Other | Group 3 (TP + VitD + P1), Group 4 (TP + P1+ P2) |
| Placebo 2Also: P2Placebo 2 (1 tablet/day) | Other | Group 2 (TP + BCAA + P2), Group 4 (TP + P1+ P2) |
Primary outcome
Changes in lactate levels compared to the placebo group
Time frame: 8 weeks
mMol/L
Changes in interleukin-6 levels compared to the placebo group
Time frame: 8 weeks
pg/ml
Changes in cratine kinase levels compared to the placebo group
Time frame: 8 weeks
U/L
Changes in testosterone cortisol ratio compared to the placebo group
Time frame: 8 weeks
mcg/dL
Changes in maximal aerobic speed compared to the placebo group
Time frame: 8 weeks
km/h
Changes in maximal oxygen consumption compared to the placebo group
Time frame: 8 weeks
ml.O2.kg/min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 22569039Howatson 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.
- Background: PubMed 32272973Zebrowska 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.
- Individual participant dataSharing planned: Yes. Results and analysis will be shared with other researchers collaborating on the research project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro J Flores Moreno, Doctor of Medical Sciences study director
Universidad de Colima
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training program, Branched-Chain Amino Acids and Vitamin D in people with Healthy Adult Male and Runners, run by Pedro Julian Flores Moreno at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Zepeda Fuentes, Master of Medical Sciences (523121538794, mzepeda6@ucol.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lactate levels compared to the placebo group (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07334054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.