The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 3/30/2019 |
| Start Date: | February 23, 2019 |
| End Date: | February 2020 |
| Contact: | Cynthia Lee, PharmD |
| Email: | clee8@pacific.edu |
| Phone: | 2099323223 |
Many adults in the United States regularly consumer energy drinks. Currently, the safety of
energy drinks is still questionable and there are many reports associating energy drinks with
adverse events including hospitalizations and deaths. Previous research shows that energy
drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher
volume (32 ounces) of energy drinks than those available in the market (24 ounces). The
purpose of this study is to study if 24-ounce energy drinks can significantly affect heart
rhythm and elevate blood pressure when compared to a placebo.
energy drinks is still questionable and there are many reports associating energy drinks with
adverse events including hospitalizations and deaths. Previous research shows that energy
drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher
volume (32 ounces) of energy drinks than those available in the market (24 ounces). The
purpose of this study is to study if 24-ounce energy drinks can significantly affect heart
rhythm and elevate blood pressure when compared to a placebo.
The study is a randomized, double blind, controlled, crossover study comparing the effect of
energy drinks and placebo on cardiovascular parameters including heart rhythm and blood
pressure.
Subjects who contact the PI for interest in study participation will be scheduled a time to
study facility for initial evaluation on eligibility criteria. At initial evaluation,
participants will be informed about the study details, presented with Informed Consent
Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to
participate. Once consented, participants will be asked a series of questions and screened
for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient
is eligible to enroll, they will be allocated a randomized identification number.
Participants will be randomly assigned to consume either two-12 oz bottles of energy drink
and two-12 oz bottles of control drink on 2 separate days. The study will occur over
approximately 8 days with each session taking about 5 hours per day. Each session will have 6
days between each other.
Participants will be expected to refrain from any products containing caffeine or alcohol 48
hours and fast 10 hours before each study visit. At the beginning of each study visit,
baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to
consuming study drinks. Repeat measurements will be obtained every 60 minutes after
consumption over 4 hours.
energy drinks and placebo on cardiovascular parameters including heart rhythm and blood
pressure.
Subjects who contact the PI for interest in study participation will be scheduled a time to
study facility for initial evaluation on eligibility criteria. At initial evaluation,
participants will be informed about the study details, presented with Informed Consent
Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to
participate. Once consented, participants will be asked a series of questions and screened
for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient
is eligible to enroll, they will be allocated a randomized identification number.
Participants will be randomly assigned to consume either two-12 oz bottles of energy drink
and two-12 oz bottles of control drink on 2 separate days. The study will occur over
approximately 8 days with each session taking about 5 hours per day. Each session will have 6
days between each other.
Participants will be expected to refrain from any products containing caffeine or alcohol 48
hours and fast 10 hours before each study visit. At the beginning of each study visit,
baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to
consuming study drinks. Repeat measurements will be obtained every 60 minutes after
consumption over 4 hours.
Inclusion Criteria:
- Healthy male or female adults 18-40 years old
- Participants must be willing to refrain from caffeine and alcohol use 48 hours prior
to each study day
- Participants must be willing to fast 10 hours prior to each study day
- Participants must have health insurance
Exclusion Criteria:
- Corrected QT (QTc) interval greater than 450 milliseconds (ms). QTc will be determined
on the ECG obtained during initial screening appointment.
- Blood pressure at initial screening appointment greater than 140/90 mmHg.
- Presence of any known medical condition confirmed through participant interview
- Concurrent use of ANY medication taken on a daily basis, to include herbal products or
supplements (exception include oral contraceptives that will be allowed if taking for
longer than 1 month)
- Current smokers or those who have smoked any cigarettes within the past month
- Pregnant or currently breastfeeding
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