Clinical trial NCT05781620: Vitamin D Supplementation in Healthy Adults in Prolonged Endurance Exercise
Official title: Effects of Vitamin D Supplementation on Biochemical Reaction and Skeletal Muscle Synthesis in Prolonged Endurance Exercise and Cluster Set Configurations of Resistance Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Panion & BF Biotech Inc.
First posted: 2023-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An independent samples and dose titration design will be used to assign participants to the experimental group or placebo group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of NT-proBNP
timeFrame: before exercise
measure: Concentration of NT-proBNP
timeFrame: immediately after exercise
measure: Concentration of NT-proBNP
timeFrame: 2-hour after exercise
measure: Concentration of NT-proBNP
timeFrame: 24-hour after exercise
measure: Concentration of cTnI
timeFrame: before exercise
measure: Concentration of cTnI
timeFrame: immediately after exercise
measure: Concentration of cTnI
timeFrame: 2-hour after exercise
measure: Concentration of cTnI
timeFrame: 24-hour after exercise
measure: Concentration of CK-MB
timeFrame: before exercise
measure: Concentration of CK-MB
timeFrame: immediately after exercise
measure: Concentration of CK-MB
timeFrame: 2-hour after exercise
measure: Concentration of CK-MB
timeFrame: 24-hour after exercise
measure: Concentration of CK
timeFrame: before exercise
measure: Concentration of CK
timeFrame: immediately after exercise
measure: Concentration of CK
timeFrame: 2-hour after exercise
measure: Concentration of CK
timeFrame: 24-hour after exercise
measure: Concentration of Testosterone
timeFrame: before exercise
measure: Concentration of Testosterone
timeFrame: immediately after exercise
measure: Concentration of Testosterone
timeFrame: 2-hour after exercise
measure: Concentration of Testosterone
timeFrame: 24-hour after exercise
measure: Concentration of Cortisol
timeFrame: before exercise
measure: Concentration of Cortisol
timeFrame: immediately after exercise
measure: Concentration of Cortisol
timeFrame: 2-hour after exercise
measure: Concentration of Cortisol
timeFrame: 24-hour after exercise
measure: Concentration of β-endorphin
timeFrame: before exercise
measure: Concentration of β-endorphin
timeFrame: immediately after exercise
measure: Concentration of β-endorphin
timeFrame: 2-hour after exercise
measure: Concentration of β-endorphin
timeFrame: 24-hour after exercise
measure: Concentration of Growth hormone
timeFrame: before exercise
measure: Concentration of Growth hormone
timeFrame: immediately after exercise
measure: Concentration of Growth hormone
timeFrame: 2-hour after exercise
measure: Concentration of Growth hormone
timeFrame: 24-hour after exercise
measure: Concentration of IGF-1
timeFrame: before exercise
measure: Concentration of IGF-1
timeFrame: immediately after exercise
measure: Concentration of IGF-1
timeFrame: 2-hour after exercise
measure: Concentration of IGF-1
timeFrame: 24-hour after exercise
measure: Concentration of TBARS
timeFrame: before exercise
measure: Concentration of TBARS
timeFrame: immediately after exercise
measure: Concentration of TBARS
timeFrame: 2-hour after exercise
measure: Concentration of TBARS
timeFrame: 24-hour after exercise
measure: Concentration of PC
timeFrame: before exercise
measure: Concentration of PC
timeFrame: immediately after exercise
measure: Concentration of PC
timeFrame: 2-hour after exercise
measure: Concentration of PC
timeFrame: 24-hour after exercise
measure: Concentration of SOD
timeFrame: before exercise
measure: Concentration of SOD
timeFrame: immediately after exercise
measure: Concentration of SOD
timeFrame: 2-hour after exercise
measure: Concentration of SOD
timeFrame: 24-hour after exercise
measure: Concentration of Catalase
timeFrame: before exercise
measure: Concentration of Catalase
timeFrame: immediately after exercise
measure: Concentration of Catalase
timeFrame: 2-hour after exercise
measure: Concentration of Catalase
timeFrame: 24-hour after exercise
measure: Concentration of TNF-α
timeFrame: before exercise
measure: Concentration of TNF-α
timeFrame: immediately after exercise
measure: Concentration of TNF-α
timeFrame: 2-hour after exercise
measure: Concentration of TNF-α
timeFrame: 24-hour after exercise
measure: Concentration of IL-8
timeFrame: before exercise
measure: Concentration of IL-8
timeFrame: immediately after exercise
measure: Concentration of IL-8
timeFrame: 2-hour after exercise
measure: Concentration of IL-8
timeFrame: 24-hour after exercise
measure: Concentration of IL-10
timeFrame: before exercise
measure: Concentration of IL-10
timeFrame: immediately after exercise
measure: Concentration of IL-10
timeFrame: 2-hour after exercise
measure: Concentration of IL-10
timeFrame: 24-hour after exercise
measure: Concentration of LDH
timeFrame: before exercise
measure: Concentration of LDH
timeFrame: immediately after exercise
measure: Concentration of LDH
timeFrame: 2-hour after exercise
measure: Concentration of LDH
timeFrame: 24-hour after exercise
measure: Concentration of IL-6
timeFrame: before exercise
measure: Concentration of IL-6
timeFrame: immediately after exercise
measure: Concentration of IL-6
timeFrame: 2-hour after exercise
measure: Concentration of IL-6
timeFrame: 24-hour after exercise
measure: Concentration of IL-15
timeFrame: before exercise
measure: Concentration of IL-15
timeFrame: immediately after exercise
measure: Concentration of IL-15
timeFrame: 2-hour after exercise
measure: Concentration of IL-15
timeFrame: 24-hour after exercise
measure: Concentration of leukocyte
timeFrame: before exercise
measure: Concentration of leukocyte
timeFrame: immediately after exercise
measure: Concentration of leukocyte
timeFrame: 2-hour after exercise
measure: Concentration of leukocyte
timeFrame: 24-hour after exercise
measure: Concentration of neutrophil
timeFrame: before exercise
measure: Concentration of neutrophil
timeFrame: immediately after exercise
measure: Concentration of neutrophil
timeFrame: 2-hour after exercise
measure: Concentration of neutrophil
timeFrame: 24-hour after exercise
measure: Concentration of eosinophil
timeFrame: before exercise
measure: Concentration of eosinophil
timeFrame: immediately after exercise
measure: Concentration of eosinophil
timeFrame: 2-hour after exercise
measure: Concentration of eosinophil
timeFrame: 24-hour after exercise
measure: Concentration of basophil
timeFrame: before exercise
measure: Concentration of basophil
timeFrame: immediately after exercise
measure: Concentration of basophil
timeFrame: 2-hour after exercise
measure: Concentration of basophil
timeFrame: 24-hour after exercise
measure: Concentration of monocyte
timeFrame: before exercise
measure: Concentration of monocyte
timeFrame: immediately after exercise
measure: Concentration of monocyte
timeFrame: 2-hour after exercise
measure: Concentration of monocyte
timeFrame: 24-hour after exercise
measure: Concentration of lymphocyte
timeFrame: before exercise
measure: Concentration of lymphocyte
timeFrame: immediately after exercise
measure: Concentration of lymphocyte
timeFrame: 2-hour after exercise
measure: Concentration of lymphocyte
timeFrame: 24-hour after exercise
measure: Concentration of CD4+
timeFrame: before exercise
measure: Concentration of CD4+
timeFrame: immediately after exercise
measure: Concentration of CD4+
timeFrame: 2-hour after exercise
measure: Concentration of CD4+
timeFrame: 24-hour after exercise
measure: Concentration of CD8+
timeFrame: before exercise
measure: Concentration of CD8+
timeFrame: immediately after exercise
measure: Concentration of CD8+
timeFrame: 2-hour after exercise
measure: Concentration of CD8+
timeFrame: 24-hour after exercise
measure: Concentration of CD19+
timeFrame: before exercise
measure: Concentration of CD19+
timeFrame: immediately after exercise
measure: Concentration of CD19+
timeFrame: 2-hour after exercise
measure: Concentration of CD19+
timeFrame: 24-hour after exercise
measure: Concentration of CD56+
timeFrame: before exercise
measure: Concentration of CD56+
timeFrame: immediately after exercise
measure: Concentration of CD56+
timeFrame: 2-hour after exercise
measure: Concentration of CD56+
timeFrame: 24-hour after exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: