Effects of a Thermogenic Dietary Supplement on Metabolic, Hemodynamic, and Mood Responses
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 35 |
Updated: | 3/30/2019 |
Start Date: | July 23, 2018 |
End Date: | October 31, 2018 |
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on REE, Cardiovascular, and Mood Responses
This a randomized, double blind, placebo controlled, crossover design study which measures
the effect of an available thermogenic dietary supplement on resting energy expenditure
(REE), blood pressure and heart rate, and mood changes in moderate caffeine consumers.
Participants will complete baseline measurements then ingest one of three pills. Once the
pill is ingested, subjects will complete four REEs along with heart rate and blood pressure
and appropriate questionnaires. Participants will return two more times, each after a one
week washout period, and complete the same protocol with the remaining supplements.
the effect of an available thermogenic dietary supplement on resting energy expenditure
(REE), blood pressure and heart rate, and mood changes in moderate caffeine consumers.
Participants will complete baseline measurements then ingest one of three pills. Once the
pill is ingested, subjects will complete four REEs along with heart rate and blood pressure
and appropriate questionnaires. Participants will return two more times, each after a one
week washout period, and complete the same protocol with the remaining supplements.
Subjects expressing interest in completing the study will be interviewed in the UMHB Human
Performance Lab (HPL) to determine whether they qualify to participate in the study. Upon
qualification, participants will be scheduled for their first testing session which will
include: a body composition analysis via an InBody 770, hunger questionnaires, VAS
questionnaires, follow up questionnaire, and 5 resting energy expenditure (REE) tests.
Participants will be randomized into an order that determines which supplement to ingest at
their testing sessions. Example: A, C, B will correspond to taking A the first session, C the
second session and so on.
Supplementation protocol: Participants will be randomized into an order that determines which
supplement to ingest at their testing sessions. Example: A, C, B will correspond to taking A
the first session, C the second session and so on. Subjects will take one pill with 8oz of
water in one minute of allotted time.
After initial REE, heart rate, blood pressure, questionnaires, and body composition tests,
subjects will ingest the first of three supplements. After ingestion, subjects will complete
four REEs every hour. At initial and 60 minutes post ingestion, ECG measurements will be
recorded using the Biopac BSL. After each REE is complete, heart rate, blood pressure, and
questionnaires will be taken and recorded. The REE will last 20 minutes, thus to ensure
ending time is at the hour mark, the REE will be started at the 40 minute time point. Once
testing is finished, subjects will return to the lab two more times with a one week washout
period to ingest the remaining supplements.
Two days prior to each of the three testing sessions, participants will record their dietary
intake via MyFitnessPal.
Performance Lab (HPL) to determine whether they qualify to participate in the study. Upon
qualification, participants will be scheduled for their first testing session which will
include: a body composition analysis via an InBody 770, hunger questionnaires, VAS
questionnaires, follow up questionnaire, and 5 resting energy expenditure (REE) tests.
Participants will be randomized into an order that determines which supplement to ingest at
their testing sessions. Example: A, C, B will correspond to taking A the first session, C the
second session and so on.
Supplementation protocol: Participants will be randomized into an order that determines which
supplement to ingest at their testing sessions. Example: A, C, B will correspond to taking A
the first session, C the second session and so on. Subjects will take one pill with 8oz of
water in one minute of allotted time.
After initial REE, heart rate, blood pressure, questionnaires, and body composition tests,
subjects will ingest the first of three supplements. After ingestion, subjects will complete
four REEs every hour. At initial and 60 minutes post ingestion, ECG measurements will be
recorded using the Biopac BSL. After each REE is complete, heart rate, blood pressure, and
questionnaires will be taken and recorded. The REE will last 20 minutes, thus to ensure
ending time is at the hour mark, the REE will be started at the 40 minute time point. Once
testing is finished, subjects will return to the lab two more times with a one week washout
period to ingest the remaining supplements.
Two days prior to each of the three testing sessions, participants will record their dietary
intake via MyFitnessPal.
Inclusion Criteria:
- Subjects will be male or female between the ages of 18-35 years
- Subjects will not consume caffeine 24 hours prior to testing
- Subjects will be daily caffeine consumers (<200mg/day prior to 12pm)
- Subject has provided written and dated informed consent to participate in the study
- Subject is willing and able to comply with the protocol
- Subject is apparently healthy and free from disease, as determined by a health history
questionnaire
- Subject agrees to log their diet 48 hours prior to each testing session
- Subject agrees to abstain from exercise 24 hours prior to each testing visit
- Subject agrees to fast for 12 hours prior to each testing visit
- Subject agrees to refrain from sleeping for one hour prior to and during each testing
session
Exclusion Criteria:
- Subject has sensitivity issues following ingestion of caffeine
- Subject currently smokes or has quit within the last 6 months
- Subject takes medication prescribed by a physician or regularly takes over the counter
medication
- Subject is allergic to any ingredient in the nutritional supplement or placebo
- Subject may be pregnant, is pregnant, is trying to become pregnant, or is
breastfeeding
- Subject reports any unusual adverse events associated with this study that in
consultation with the study investigators or their doctor recommends removal from the
study
- Subject consumes >200 mg of caffeine before 12pm
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