Vitamin B Complex Improved Exercise Performance and Anti-fatigue

Fatigue Clinical Trial

Official title:

The Functional Evaluation on Antifatigue and Improving Sports Performance by Vitamin B Complex of BULIKELAO Sugar-coated Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586295
• Other study ID #: 20-037-A2
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: June 26, 2021

Study information

• Verified date: October 2022
• Source: National Taiwan Sport University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study was to evaluate potential beneficial effects of TTFD® EX PLUS (Prince Pharmaceutical Co., Ltd., Yunlin County, Taiwan) on fatigue and ergogenic functions following physiological challenge. The test used a double-blind crossover design and supplementation for 28 days. 32 male and female 20-30 year-old subjects were divided into two groups in a balanced order according to each individual's initial maximal oxygen uptake and were assigned to receive a placebo with equal gender (non TTFD® EX PLUS with same color/day, n=16, 8 male and 8 female) or TTFD® EX PLUS (600mg/tablet/day, n=16, 8 male and 8 female) every morning. After the intervention, there were 28 days of wash-out, during which time the subjects did not receive further interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 26, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• >20 years old
• >health

Exclusion Criteria:

• No smoking
• drinking habits
• no nutritional supplements or medications
• no food allergies
• normal liver and kidney function
• no diabetes and other chronic diseases

Related Conditions & MeSH terms

• Exercise Performance
• Fatigue

Intervention

Other:
• Placebo
Microcrystalline a-cellulose, shellac, calcium hydrogen phosphate, edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, palm wax.
• EX plus
Furanthiamine hydrochloride (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12), DL-alpha-tocopheryl acetate 50% (DL-alpha-tocopheryl acetate, sucrose, caprylic acid) Sodium alkenyl succinate starch, corn starch, water, sodium aluminosilicate), shellac, calcium hydrogen phosphate, edible yellow No. 4, edible yellow No. 5, ?-oryzanol (?-oryzanol, rice bran powder ), sucrose, silica, inositol, taurine, talc, oxidized starch, gelatin, magnesium stearate, calcium panpolyate, microcrystalline a-cellulose, riboflavin (vitamin B2), palmar wax.

Locations

Country	Name	City	State
Taiwan	Graduate Institute of Sports Science, National Taiwan Sport University	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan Sport University	Prince Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise endurance exhaustion time	Investigators adopted a double-blind test in which the volunteers, based on their basal maximal oxygen consumption (VO2max). before and after intervention, the individual basal VO2max during pretest was used as a reference to adjust the individually appropriate exercise intensity to measure exhaustive endurance (85% VO2max) and recording the running time from begin to exhaust.	28 days
Primary	Clinical Biochemistry of lactate level	For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase. Serum lactate (mmol/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).	28 days
Primary	Clinical Biochemistry of ammonia level	For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase. Serum ammonia (umol/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).	28 days
Primary	Clinical Biochemistry of CK level	For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase. Serum CK (U/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).	28 days
Primary	Clinical Biochemistry of glucose level	For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 5 (E5), 10 (E10), 15 (E15), and 30 (E30) min during the exercise phase, and 20 (R20), 40 (R40), 60 (R60), and 90 (R90) min in the recovery phase. Serum glucose (mg/dL), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).	28 days