Clinical trial NCT03678116: Effects of a Thermogenic Dietary Supplement on Metabolic, Hemodynamic, and Mood Responses
Official title: Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on REE, Cardiovascular, and Mood Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Metabolism
Heart Rate
Blood Pressure
Mood
Keywords: caffeine
metabolism
Lead sponsor: University of Mary Hardin-Baylor
Sponsor class: OTHER
Collaborators: name: Dymatize Inc.
First posted: 2018-09-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three groups: placebo, caffeine (plus Teacrine and Cayenne) and caffeine (plus Teacrine)
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Resting Energy Expenditure (REE)
timeFrame: REE completed every hour for four hours post ingestion
measure: Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Heart Rate
timeFrame: Heart rate taken every hour for four hours post ingestion
measure: Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Blood Pressure
timeFrame: Blood pressure taken every hour for four hours post ingestion
measure: Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Mood Responses
timeFrame: VAS values recorded every hour for four hours post ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Belton
country: United States
facility: UMHB Human Performance Lab
state: Texas
Study officials:
affiliation: UMHB Human Performance Lab
name: Lemuel W Taylor IV, PhD
role: PRINCIPAL_INVESTIGATOR
References: