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Unable to recruit enough subjects
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy Drink | Experimental | Energy drink, 2 oz twice daily for 7 days |
|
| Placebo | Placebo Comparator | Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Drink | Dietary Supplement | Energy drink, 2oz twice daily for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Office Systolic Blood Pressure | SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days. | At baseline and 7 days post energy drink and placebo consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Office DBP After a Single Energy Shot and After Chronic Consumption | DBP = Diastolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days. | At baseline and 7 days post energy drink and placebo consumption |
| Max Heart Rate After a Single Shot and After Chronic Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shah Sachin, Pharm.D. | David Grant Medical Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Energy Drink, Then Placebo | Energy drink, 2 oz twice daily for 7 days, washout period, then Placebo: Water, lime juice and cherry flavoring |
| FG001 | Placebo, Then Energy Drink | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Energy drink: Energy drink, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Office Systolic Blood Pressure | SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days. | Posted | Mean | Standard Deviation | mmHg | At baseline and 7 days post energy drink and placebo consumption |
|
During the study, for up to 7 days per intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Energy Drink | Energy drink: Energy drink, 2oz twice daily for 7 days |
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Small sample size and limited to 7 days of consumption.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sachin Shah | DavidGrant | 707-423-3277 | sshah@pacific.edu |
| ID | Term |
|---|---|
| D061215 | Energy Drinks |
| D014867 | Water |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo |
| Other |
Water, lime juice and cherry flavoring |
|
|
Maximum heart rate measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days |
| At baseline and 7 days post energy drink and placebo consumption |
| Max PR-interval After a Single Shot and After Chronic Consumption | Maximum PR-interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption |
| Max QRS Duration After a Single Shot and After Chronic Consumption | Max QRS duration measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption |
| Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 | Max QT interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption |
| Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 | Max QTc interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | At baseline and 7 days post energy drink and placebo consumption |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Office DBP After a Single Energy Shot and After Chronic Consumption | DBP = Diastolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days. | Posted | Mean | Standard Deviation | mmHg | At baseline and 7 days post energy drink and placebo consumption |
|
|
|
| Secondary | Max Heart Rate After a Single Shot and After Chronic Consumption | Maximum heart rate measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | Posted | Mean | Standard Deviation | beats per minute | At baseline and 7 days post energy drink and placebo consumption |
|
|
|
| Secondary | Max PR-interval After a Single Shot and After Chronic Consumption | Maximum PR-interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | Posted | Mean | Standard Deviation | msec | At baseline and 7 days post energy drink and placebo consumption |
|
|
|
| Secondary | Max QRS Duration After a Single Shot and After Chronic Consumption | Max QRS duration measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | Posted | Mean | Standard Deviation | msec | At baseline and 7 days post energy drink and placebo consumption |
|
|
|
| Secondary | Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 | Max QT interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | Posted | Mean | Standard Deviation | msec | At baseline and 7 days post energy drink and placebo consumption |
|
|
|
| Secondary | Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 | Max QTc interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days | Posted | Mean | Standard Deviation | msec | At baseline and 7 days post energy drink and placebo consumption |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo | Placebo: Water, lime juice and cherry flavoring | 0 | 26 | 0 | 26 |
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| D006878 |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |