## Protocol Section
### Identification Module
**NCT ID:** NCT06431035

**Brief Title:** Caffeine & Bodybuilding Dehydration Ability

**Official Title:** Effect of Caffeinated Chewing Gum on Dehydration Ability in Bodybuilding Athletes: a Crossover Trial

#### Organization Study ID Info
**ID:** 113-3
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan Sport University
### Status Module
#### Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

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

**Type:** ACTUAL

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

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-31

**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

#### 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:** False

### Description Module

**Brief Summary:** 15-20 trained bodybuilding athletes 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 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight.

**Detailed Description:** The purpose of this study was to investigate the effect of caffeinated chewing gum on dehydration ability in bodybuilding athletes. Methods: 15-20 trained bodybuilding athletes 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 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight. Record time from exercise to completion of dehydration, heart rate, HRV, energy expenditure, fat oxidation rate and carbohydrate oxidation rate.

### Conditions Module

**Conditions:**

- Caffeine

- Placebo

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** The participants were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Using placebo chewing gum

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Chewing caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) for 10 minutes before test.

**Intervention Names:**

- Dietary Supplement: caffeine

**Label:** caffeine gum

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Chewing placebo gum (without caffeine) for 10 minutes before test.

**Intervention Names:**

- Dietary Supplement: caffeine

**Label:** placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- caffeine gum

- placebo

**Description:** The participants chewed either caffeine gum (5 mg/kg for 10 minutes per chew) or a placebo (10 minutes per chew, using regular gum).

**Name:** caffeine

**Other Names:**

- plocabo gum

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** The participants start dehydration until dehydrated to 2% of their original body weight.

**Measure:** dehydration speed

**Time Frame:** 15 minutes after intervention

#### Secondary Outcomes

**Description:** The energy expenditure during dehydration

**Measure:** energy expenditure

**Time Frame:** 15 minutes after intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* having won the top 8 places in a national competition,
* having no cardiovascular or joint diseases
* being an adult male

Exclusion Criteria:

* no top 8 finishes at national level
* cardiovascular or joint disease, or any other condition that could be impaired by exercise
* female and underage participants
* previous caffeine allergy

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chiuch@ntus.edu.tw

**Name:** ChihHui Chiu, PhD

**Phone:** +886-4-22213108

**Phone Ext:** 3486

**Role:** CONTACT

**Contact 2:**

**Email:** jakic1114@ntus.edu.tw

**Name:** Che-Hsiu Chen, PhD

**Phone:** +886-4-22213108

**Phone Ext:** 3108

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Taichung

**Contacts:**

***Contact 1:***

- **Email:** chiuch@ntus.edu.tw

- **Name:** ChihHui Chiu, PhD

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** National Taiwan University of Sport

**Status:** RECRUITING

**Zip:** 404

#### Overall Officials

**Official 1:**

**Affiliation:** National Taiwan University of Sport

**Name:** ChihHui Chiu, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Only participant number and 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: 488910

- Type Abbrev: Prot

- Upload Date: 2024-05-24T06:10

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014883

- Term: Water-Electrolyte Imbalance

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6883

- Name: Dehydration

- Relevance: HIGH

- As Found: Dehydration

- ID: M17624

- Name: Water-Electrolyte Imbalance

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003681

- Term: Dehydration

### 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
