## Protocol Section
### Identification Module
**NCT ID:** NCT06430996

**Brief Title:** Caffeinated Chewing Gum on 400-meter Performance

**Official Title:** Effects of Caffeinated Chewing Gum on 400-meter Performance and Fatigue Index of Sprinters: a Crossover Trial

#### Organization Study ID Info
**ID:** 113-2
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan Sport University
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-08

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-08
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** National Science and Technology Council

#### Lead Sponsor

**Class:** OTHER

**Name:** Chih-Hui Chiu

#### Responsible Party

**Investigator Affiliation:** National Taiwan Sport University

**Investigator Full Name:** Chih-Hui Chiu

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. The outcomes are Running-Based Anaerobic Sprint Test and 400-meter sprint test was performed.

**Detailed Description:** The purpose of this study was to investigate the effect of caffeinated chewing gum on 400-meter sprint performance. 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent a Running-Based Anaerobic Sprint Test. After a 30-minute break, a 400-meter sprint test was performed. The blood lactate concentration were collected before and after 400-meter sprint from finger. Saliva samples were predicted to be collected before chewing gum, before the RAST, and after a 400-meter sprint. Saliva samples will be analyzed for caffeine and α-amylase concentrations in saliva.

### Conditions Module

**Conditions:**

- Caffeine

- Placebo

**Keywords:**

- exercise performance

- fatigue index

- α amylase

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The participants chewing caffeine gum 10 minutes before exercise

**Intervention Names:**

- Dietary Supplement: caffeine

**Label:** caffeine gum

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The participants chewing placebo gum 10 minutes before exercise

**Intervention Names:**

- Dietary Supplement: caffeine

**Label:** placebo gum

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- caffeine gum

- placebo gum

**Description:** The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent tests.

**Name:** caffeine

**Other Names:**

- plocabo gum

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Measure the fatigue index (%)

**Measure:** Running-Based Anaerobic Sprint Test (RAST)

**Time Frame:** 15 minutes after intervention

**Description:** Measure the 400-meter completion time (seconds)

**Measure:** 400-meter sprinting

**Time Frame:** 30 minutes after RAST

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 6 years of professional short sprinting training
* 6 months of ongoing training, and
* 3 months of recovery from sports injuries such as strains and sprains.

Exclusion Criteria:

* Non-specialized sprinters.
* has not trained regularly for the past 6 months.
* has recovered from an athletic injury.
* less than 3 months of recovery from a sports injury, or participants with epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 20 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taichung

**Country:** Taiwan

**Facility:** National Taiwan University of Sport

**Zip:** 404

#### Overall Officials

**Official 1:**

**Affiliation:** Sport Science Research Center

**Name:** ChihHui Chiu, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Only participant number and relevant experimental data are provided.

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-05-23

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 467644

- Type Abbrev: Prot

- Upload Date: 2024-05-24T06:04

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000697

- Term: Central Nervous System Stimulants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000058915

- Term: Purinergic P1 Receptor Antagonists

- ID: D000058914

- Term: Purinergic Antagonists

- ID: D000058905

- Term: Purinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M5373

- Name: Caffeine

- Relevance: HIGH

- As Found: 800

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: T370

- Name: Caffeine

- Relevance: HIGH

- As Found: 800

### Intervention Browse Module - Meshes

- ID: D000002110

- Term: Caffeine

### Misc Info Module

- Version Holder: 2024-05-31
