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Completed

NCT Number: NCT05586295

Vitamin B Complex Improved Exercise Performance and Anti-fatigue

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.

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Key information

Conditions

Exercise Performance Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Institute of Sports Science, National Taiwan Sport University

Taoyuan, 33301, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Microcrystalline α-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

Other

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, γ-oryzanol (γ-oryzanol, rice bran powder ), sucrose, silica, inositol, taurine, talc, oxidized starch, gelatin, magnesium stearate, calcium panpolyate, microcrystalline α-cellulose, riboflavin (vitamin B2), palmar wax.

Primary outcomes

  1. Exercise endurance exhaustion time

    Time frame: 28 days

    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.

  2. Clinical Biochemistry of lactate level

    Time frame: 28 days

    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).

  3. Clinical Biochemistry of ammonia level

    Time frame: 28 days

    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).

  4. Clinical Biochemistry of CK level

    Time frame: 28 days

    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).

  5. Clinical Biochemistry of glucose level

    Time frame: 28 days

    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).

Sponsors and collaborators

Lead sponsor

National Taiwan Sport University

Other

Collaborators

  • Prince Pharmaceutical Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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