Healthy
Conditions
Brief summary
The purpose of this study is to investigate the effects of vitamin D supplementation on biochemistry response and skeletal muscle synthesis in prolonged endurance exercise.
Detailed description
Endurance exercise mode will be used to evaluate the effects of vitamin D supplementation on cardiac biomarkers, metabolic hormones, oxidative damage, and inflammation responses. An independent samples and dose titration design will be used to assign 30 participants to the experimental group (n = 15) or placebo group (n = 15). All participants in the experimental group will have serum 25(OH)D concentrations higher than 48 ng/mL after supplementation period. After the prolonged endurance exercise test, the blood samples will be collected for analyzing biomarkers. Data will be analyzed by Two-way mixed design ANOVA.
Interventions
DIETARY_SUPPLEMENTVitamin D
Participants received 5,000 IU of vitamin D orally twice daily for 4 weeks. If the serum 25(OH)D concentration exceeds 48 ng/mL, the intervention remains the same. However, if the serum 25(OH)D concentration is under 48 ng/mL, the dosage would increase by 2,500 IU. The principle remains the same at week 6.
DIETARY_SUPPLEMENTMedium-chain triglycerides
Participants received the same amount of placebo matching vitamin D orally twice daily.
Sponsors
Panion & BF Biotech Inc.
Taipei Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
A double-blind, matched-pair study design
Intervention model description
An independent samples and dose titration design will be used to assign participants to the experimental group or placebo group.
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* The volunteers included have conditions as stated below : 1. male adult between 20-40 years old without any history of cardiovascular, liver, kidney and diabetes disease 2. no acute sport injury 3. male adult whose concentration of 25(OH)D is under 30 ng/mL, and maximal oxygen consumption is over 40 ml/kg/min 4. did not participated in any clinical trials or research in the last 3 months before our experiment 5. no supplements were taken during the experimental period 6. were requested to maintain their regular daily life style and avoid alcohol intake
Exclusion criteria
* The volunteers were excluded if they have the situation stated below: 1. history of cardiovascular, liver, kidney and diabetes disease 2. acute sport injury 3. their concentration of 25(OH)D is over 30 ng/mL, or maximal oxygen consumption is under 40 ml/kg/mint 4. participated in any clinical trials or experimental research in the last 3 months before our experiment 5. taking supplement during the experimental period 6. did not maintain their regular eating habit or drink alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of LDH | before exercise |
| Concentration of IL-6 | before exercise |
| Concentration of NT-proBNP | before exercise |
| Concentration of IL-8 | before exercise |
| Concentration of cTnI | before exercise |
| Concentration of CK-MB | before exercise |
| Concentration of IL-10 | before exercise |
| Concentration of CK | before exercise |
| Concentration of Testosterone | before exercise |
| Concentration of Cortisol | before exercise |
| Concentration of β-endorphin | before exercise |
| Concentration of Growth hormone | before exercise |
| Concentration of IGF-1 | before exercise |
| Concentration of TBARS | before exercise |
| Concentration of PC | before exercise |
| Concentration of SOD | before exercise |
| Concentration of Catalase | before exercise |
| Concentration of TNF-α | before exercise |
| Concentration of IL-15 | before exercise |
| Concentration of leukocyte | before exercise |
| Concentration of neutrophil | before exercise |
| Concentration of eosinophil | before exercise |
| Concentration of basophil | before exercise |
| Concentration of monocyte | before exercise |
| Concentration of lymphocyte | before exercise |
| Concentration of CD4+ | before exercise |
| Concentration of CD8+ | before exercise |
| Concentration of CD19+ | before exercise |
| Concentration of CD56+ | before exercise |
Countries
Taiwan
Outcome results
None listed