Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05998096 |
Other study ID # |
IRB-23-95 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2023 |
Est. completion date |
April 23, 2024 |
Study information
Verified date |
June 2024 |
Source |
Lindenwood University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to evaluate the changes in energy expenditure, fat oxidation,
reaction time, and perceptual indicators of energy and focus after acute ingestion of a
caffeine-based energy drink. Approximately 60 healthy adults aged 18-50 will be recruited for
a randomized, double-blind, placebo-controlled study. They will undergo baseline measurements
for energy expenditure, fat and carbohydrate oxidation, reaction time, cognition, and
perceptual indicators of energy, focus, and concentration. After 28 days, these measurements
will be taken again, comparing the effects of a caffeine-based energy drink versus a placebo.
Description:
The study will be conducted using a randomized, double-blind, placebo-controlled, parallel
study design. Approximately 60 healthy men and women between the ages of 18 - 55 years of age
will be recruited to participate in this study. Prior to beginning the study, all
participants will sign an IRB-approved informed consent document and complete a health
history questionnaire to determine study eligibility. All participants will report to the
laboratory for all study visits between 0600 - 1000 hours. Prior to each study visit,
participants will be asked to abstain from exercise, tobacco, nicotine, and alcohol for 12
hours and observe an overnight (8 - 10 hours) fast including caffeine. Study visit 1 will be
a screening visit where participants will first sign an IRB-approved informed consent
document. To determine eligibility, participants will then complete a health and medical
history form and have their height and weight assessed along with their resting heart rate
and blood pressure. If determined eligible, study participants will then have their body
composition assessed and then be asked to record their past 24-hour intake of food and fluid.
This form will be copied and all participants will be instructed to replicate this diet prior
to each visit.
Study visits 2 and 3 will be identical and separated by approximately 28 days whereby each
study participant will have ingested a single dose of their assigned beverage each day
between visits 2 and 3. Prior to these visits, participants will not be allowed to exercise
within 24 hours of each subsequent study visit and may only partake in a light workout two
days prior to their study visit. Participants will be instructed to follow an overnight fast
whereby no food or fluid with calories will be consumed for the 8 to 10-hour period prior to
each study visit. Water intake will be encouraged during this time for appropriate hydration
status. Upon arrival for study visits 2 and 3, body mass will be assessed before having their
body temperature, resting heart rate, and blood pressure assessed. From there, participants
will be instructed to complete simple and choice reaction time and cognition assessments
using a DynaVision board. After cognition assessments are completed, visual analog scales
will be completed to assess perceived levels of energy, focus, and concentration. Finally,
participants will then complete a resting metabolic assessment to evaluate rates of calorie
burning (energy expenditure), rate of fat oxidation, and amount of fat oxidized. After
completion of all assessments, participants will ingest their assigned dose of beverage. Each
participant will be given 15 minutes to ingest their assigned beverage. As soon as the entire
beverage is consumed, the study protocol timer will be activated and all subsequent
assessments will occur as outlined. During visit 2 (dose 1) and visit 3 (dose 28),
participants will have energy expenditure and fat oxidation assessments completed 0, 30, 60,
90, and 120 minutes after ingestion while cognition, hemodynamics, and VAS will be evaluated
0, 60, and 120 minutes.
Participants will be assigned to each group in a randomized, double-blind, placebo-controlled
fashion with parallel groups that are matched according to BMI and gender. This will ensure
each study condition has similar numbers of males and females that are of similar body mass
index levels. After completion of study visit 2, participants will be provided with a 14-day
supply of their assigned beverage. After 14 days, participants must return to the laboratory
to pick up their remaining assigned beverage and communicate with research staff about
compliance, adverse events, etc. After 28 days of supplementation, participants will return
to the laboratory for study visit 3, which will complete their participation in the study.