Trial Outcomes & Findings for Impact of Energy Drinks on Cardiovascular Endpoints (NCT NCT01329679)

NCT ID: NCT01329679

Last Updated: 2020-09-09

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: At baseline and 7 days post energy drink and placebo consumption
• Results posted on: 2020-09-09

Participant Flow

Participant milestones

Measure	Energy Drink, Then Placebo Energy drink, 2 oz twice daily for 7 days, washout period, then Placebo: Water, lime juice and cherry flavoring	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
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Energy Drinks on Cardiovascular Endpoints

Baseline characteristics by cohort

Measure	All Study Participants n=26 Participants Energy drink: Energy drink, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous Age	28.3 years STANDARD_DEVIATION 5.77 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	20 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	20 participants n=93 Participants
Race/Ethnicity, Customized African American	2 participants n=93 Participants
Race/Ethnicity, Customized Asian	2 participants n=93 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=93 Participants
Region of Enrollment United States	26 participants n=93 Participants

PRIMARY outcome

Timeframe: At baseline and 7 days post energy drink and placebo consumption

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

Outcome measures

Measure	Energy Drink n=26 Participants Energy drink: Energy drink, 2oz twice daily for 7 days	Placebo n=26 Participants Placebo: Water, lime juice and cherry flavoring
Change in Office Systolic Blood Pressure SBP at baseline	128 mmHg Standard Deviation 9.98	123 mmHg Standard Deviation 8.49
Change in Office Systolic Blood Pressure SBP at Day 7	127 mmHg Standard Deviation 9.88	124 mmHg Standard Deviation 8.29

SECONDARY outcome

Timeframe: At baseline and 7 days post energy drink and placebo consumption

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

Outcome measures

Measure	Energy Drink n=26 Participants Energy drink: Energy drink, 2oz twice daily for 7 days	Placebo n=26 Participants Placebo: Water, lime juice and cherry flavoring
Office DBP After a Single Energy Shot and After Chronic Consumption Baseline	82.7 mmHg Standard Deviation 7.79	79.0 mmHg Standard Deviation 6.80
Office DBP After a Single Energy Shot and After Chronic Consumption Day 7	82.2 mmHg Standard Deviation 6.84	78.7 mmHg Standard Deviation 6.33

SECONDARY outcome

Timeframe: At baseline and 7 days post energy drink and placebo consumption

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

Outcome measures

Measure	Energy Drink n=26 Participants Energy drink: Energy drink, 2oz twice daily for 7 days	Placebo n=26 Participants Placebo: Water, lime juice and cherry flavoring
Max Heart Rate After a Single Shot and After Chronic Consumption Baseline	69.8 beats per minute Standard Deviation 9.50	70.3 beats per minute Standard Deviation 8.41
Max Heart Rate After a Single Shot and After Chronic Consumption Day 7	68.1 beats per minute Standard Deviation 9.21	67 beats per minute Standard Deviation 7.7

SECONDARY outcome

Timeframe: At baseline and 7 days post energy drink and placebo consumption

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

Outcome measures

Measure	Energy Drink n=26 Participants Energy drink: Energy drink, 2oz twice daily for 7 days	Placebo n=26 Participants Placebo: Water, lime juice and cherry flavoring
Max PR-interval After a Single Shot and After Chronic Consumption Baseline	166 msec Standard Deviation 18.8	161 msec Standard Deviation 17.3
Max PR-interval After a Single Shot and After Chronic Consumption Day 7	164 msec Standard Deviation 15	164 msec Standard Deviation 16.7

SECONDARY outcome

Timeframe: At baseline and 7 days post energy drink and placebo consumption

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

Outcome measures

Measure	Energy Drink n=26 Participants Energy drink: Energy drink, 2oz twice daily for 7 days	Placebo n=26 Participants Placebo: Water, lime juice and cherry flavoring
Max QRS Duration After a Single Shot and After Chronic Consumption Baseline	92.1 msec Standard Deviation 9.18	92.3 msec Standard Deviation 9.26
Max QRS Duration After a Single Shot and After Chronic Consumption Day 7	94.8 msec Standard Deviation 10.5	93.4 msec Standard Deviation 8.76

SECONDARY outcome

Timeframe: At baseline and 7 days post energy drink and placebo consumption

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

Outcome measures

Measure	Energy Drink n=26 Participants Energy drink: Energy drink, 2oz twice daily for 7 days	Placebo n=26 Participants Placebo: Water, lime juice and cherry flavoring
Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 Baseline	414 msec Standard Deviation 21.9	412 msec Standard Deviation 16.2
Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 Day 7	422 msec Standard Deviation 21.2	418 msec Standard Deviation 21

SECONDARY outcome

Timeframe: At baseline and 7 days post energy drink and placebo consumption

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

Outcome measures

Measure	Energy Drink n=26 Participants Energy drink: Energy drink, 2oz twice daily for 7 days	Placebo n=26 Participants Placebo: Water, lime juice and cherry flavoring
Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 Baseline	422 msec Standard Deviation 15.3	424 msec Standard Deviation 18
Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7 Day 7	426 msec Standard Deviation 20.1	419 msec Standard Deviation 21.5

Adverse Events

Energy Drink

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sachin Shah

DavidGrant

Phone: 707-423-3277

Email: sshah@pacific.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place