Vitamin B Complex Improved Exercise Performance and Anti-fatigue

NCT ID: NCT05586295

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2021-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exercise Performance Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Group Type EXPERIMENTAL

EX plus

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

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.

Intervention Type OTHER

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, 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prince Pharmaceutical Co., Ltd

UNKNOWN

Sponsor Role collaborator

National Taiwan Sport University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chi-Chang Huang

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Graduate Institute of Sports Science, National Taiwan Sport University

Taoyuan District, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-037-A2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.