## Protocol Section
### Identification Module
**NCT ID:** NCT01329679

**Brief Title:** Impact of Energy Drinks on Cardiovascular Endpoints

**Official Title:** Effects of Single and Multiple Energy Shots on Blood Pressure and Electrocardiographic Parameters: A Randomized, Double Blind, Crossover, Placebo-controlled Trial

#### Organization Study ID Info
**ID:** FWH20110111H
#### Organization
**Class:** FED
**Full Name:** David Grant U.S. Air Force Medical Center
### Status Module
#### Completion Date
**Date:** 2013-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-09-09

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-24

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2013-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-01-10

**Type:** ESTIMATED

**Results First Submit Date:** 2016-08-29

**Results First Submit QC Date:** 2016-11-13

#### Start Date
**Date:** 2011-04

**Type:** ACTUAL

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2011-04-06
**Type:** ESTIMATED
**Study First Submit Date:** 2011-04-04
**Study First Submit QC Date:** 2011-04-05
**Why Stopped:** Unable to recruit enough subjects
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** David Grant U.S. Air Force Medical Center

#### Responsible Party

**Investigator Affiliation:** David Grant U.S. Air Force Medical Center

**Investigator Full Name:** Sachin Shah

**Investigator Title:** Assistant Professor of Pharmacy Practice

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects.

Study design: Double blind, placebo controlled, cross-over

Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions.

Intervention: Energy drink or Placebo

Primary outcome: Change in office systolic blood pressure

### Conditions Module

**Conditions:**

- Healthy Volunteers

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 26

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Energy drink, 2 oz twice daily for 7 days

**Intervention Names:**

- Dietary Supplement: Energy Drink

**Label:** Energy Drink

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Energy Drink

**Description:** Energy drink, 2oz twice daily for 7 days

**Name:** Energy Drink

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Water, lime juice and cherry flavoring

**Name:** Placebo

**Other Names:**

- Water, lime juice and cherry flavoring

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.

**Measure:** Change in Office Systolic Blood Pressure

**Time Frame:** At baseline and 7 days post energy drink and placebo consumption

#### Secondary Outcomes

**Description:** DBP = Diastolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.

**Measure:** Office DBP After a Single Energy Shot and After Chronic Consumption

**Time Frame:** At baseline and 7 days post energy drink and placebo consumption

**Description:** Maximum heart rate measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days

**Measure:** Max Heart Rate After a Single Shot and After Chronic Consumption

**Time Frame:** At baseline and 7 days post energy drink and placebo consumption

**Description:** Maximum PR-interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days

**Measure:** Max PR-interval After a Single Shot and After Chronic Consumption

**Time Frame:** At baseline and 7 days post energy drink and placebo consumption

**Description:** Max QRS duration measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days

**Measure:** Max QRS Duration After a Single Shot and After Chronic Consumption

**Time Frame:** At baseline and 7 days post energy drink and placebo consumption

**Description:** Max QT interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days

**Measure:** Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7

**Time Frame:** At baseline and 7 days post energy drink and placebo consumption

**Description:** Max QTc interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days

**Measure:** Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7

**Time Frame:** At baseline and 7 days post energy drink and placebo consumption

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy volunteers between ages 18-40 years
* ONLY "as needed" use of ibuprofen or acetamenophen
* Active duty military
* DoD beneficiary or Civilian Government Employees

Exclusion Criteria:

* No other co-morbid conditions
* No active prescription or OTC drug use
* Not pregnant or planning to become pregnant during study participation

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** David Grant Medical Center

**Name:** Shah Sachin, Pharm.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

#### Removed Countries

- Country: United States

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Energy Drink

**Description:** Energy drink: Energy drink, 2oz twice daily for 7 days

**ID:** EG000

**Other Num at Risk:** 26

**Serious Number At Risk:** 26

**Title:** Energy Drink

**Group ID:** EG001

**Title:** Placebo

**Description:** Placebo: Water, lime juice and cherry flavoring

**ID:** EG001

**Other Num at Risk:** 26

**Serious Number At Risk:** 26

**Title:** Placebo

**Frequency Threshold:** 0

**Time Frame:** During the study, for up to 7 days per intervention

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 26

**Units:** Participants

### Group

**ID:** BG000

**Title:** All Study Participants

**Description:** Energy drink: Energy drink, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 26

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 5.77

**Value:** 28.3

**Class Title:** Age

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 20

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

**Class Title:** Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** African American

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Hispanic

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 26

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Small sample size and limited to 7 days of consumption.
### Point of Contact
**Email:** sshah@pacific.edu
**Organization:** DavidGrant
**Phone:** 707-423-3277
**Title:** Sachin Shah
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.98
- **Upper Limit:** 
- **Value:** 128
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.49
- **Upper Limit:** 
- **Value:** 123
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.88
- **Upper Limit:** 
- **Value:** 127
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.29
- **Upper Limit:** 
- **Value:** 124
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.79
- **Upper Limit:** 
- **Value:** 82.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.80
- **Upper Limit:** 
- **Value:** 79.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.84
- **Upper Limit:** 
- **Value:** 82.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.33
- **Upper Limit:** 
- **Value:** 78.7
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.50
- **Upper Limit:** 
- **Value:** 69.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.41
- **Upper Limit:** 
- **Value:** 70.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.21
- **Upper Limit:** 
- **Value:** 68.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.7
- **Upper Limit:** 
- **Value:** 67
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.8
- **Upper Limit:** 
- **Value:** 166
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 17.3
- **Upper Limit:** 
- **Value:** 161
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15
- **Upper Limit:** 
- **Value:** 164
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 16.7
- **Upper Limit:** 
- **Value:** 164
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.18
- **Upper Limit:** 
- **Value:** 92.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.26
- **Upper Limit:** 
- **Value:** 92.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.5
- **Upper Limit:** 
- **Value:** 94.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.76
- **Upper Limit:** 
- **Value:** 93.4
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 21.9
- **Upper Limit:** 
- **Value:** 414
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 16.2
- **Upper Limit:** 
- **Value:** 412
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 21.2
- **Upper Limit:** 
- **Value:** 422
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 21
- **Upper Limit:** 
- **Value:** 418
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.3
- **Upper Limit:** 
- **Value:** 422
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18
- **Upper Limit:** 
- **Value:** 424
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 20.1
- **Upper Limit:** 
- **Value:** 426
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 21.5
- **Upper Limit:** 
- **Value:** 419
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline and 7 days post energy drink and placebo consumption
**Title:** Change in Office Systolic Blood Pressure
**Type:** PRIMARY
**Unit of Measure:** mmHg
##### Group
**Description:** Energy drink: Energy drink, 2oz twice daily for 7 days
**ID:** OG000
**Title:** Energy Drink
##### Group
**Description:** Placebo: Water, lime juice and cherry flavoring
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** DBP = Diastolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline and 7 days post energy drink and placebo consumption
**Title:** Office DBP After a Single Energy Shot and After Chronic Consumption
**Type:** SECONDARY
**Unit of Measure:** mmHg
##### Group
**Description:** Energy drink: Energy drink, 2oz twice daily for 7 days
**ID:** OG000
**Title:** Energy Drink
##### Group
**Description:** Placebo: Water, lime juice and cherry flavoring
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** Maximum heart rate measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline and 7 days post energy drink and placebo consumption
**Title:** Max Heart Rate After a Single Shot and After Chronic Consumption
**Type:** SECONDARY
**Unit of Measure:** beats per minute
##### Group
**Description:** Energy drink: Energy drink, 2 oz twice daily for 7 days
**ID:** OG000
**Title:** Energy Drink
##### Group
**Description:** Placebo: Water, lime juice and cherry flavoring
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** Maximum PR-interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline and 7 days post energy drink and placebo consumption
**Title:** Max PR-interval After a Single Shot and After Chronic Consumption
**Type:** SECONDARY
**Unit of Measure:** msec
##### Group
**Description:** Energy drink, 2oz twice daily for 7 days
**ID:** OG000
**Title:** Energy Drink
##### Group
**Description:** Placebo: Water, lime juice and cherry flavoring
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** Max QRS duration measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline and 7 days post energy drink and placebo consumption
**Title:** Max QRS Duration After a Single Shot and After Chronic Consumption
**Type:** SECONDARY
**Unit of Measure:** msec
##### Group
**Description:** Energy drink: Energy drink, 2oz twice daily for 7 days
**ID:** OG000
**Title:** Energy Drink
##### Group
**Description:** Placebo: Water, lime juice and cherry flavoring
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** Max QT interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline and 7 days post energy drink and placebo consumption
**Title:** Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7
**Type:** SECONDARY
**Unit of Measure:** msec
##### Group
**Description:** Energy drink: Energy drink, 2oz twice daily for 7 days
**ID:** OG000
**Title:** Energy Drink
##### Group
**Description:** Placebo: Water, lime juice and cherry flavoring
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** Max QTc interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At baseline and 7 days post energy drink and placebo consumption
**Title:** Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7
**Type:** SECONDARY
**Unit of Measure:** msec
##### Group
**Description:** Energy drink: Energy drink, 2oz twice daily for 7 days
**ID:** OG000
**Title:** Energy Drink
##### Group
**Description:** Placebo: Water, lime juice and cherry flavoring
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Energy drink, 2 oz twice daily for 7 days, washout period, then Placebo: Water, lime juice and cherry flavoring
**ID:** FG000
**Title:** Energy Drink, Then Placebo
#### Group
**Description:** Placebo: Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days, washout period, then energy drink, 2 oz twice daily for 7 days
**ID:** FG001
**Title:** Placebo, Then Energy Drink
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True