Effects of a Thermogenic Dietary Supplement on Metabolic, Hemodynamic, and Mood Responses

• ClinicalTrials.gov Identifier: NCT03678116
• Recruitment Status: Completed
• First Posted: September 19, 2018
• Last Update Posted: March 28, 2019
• Sponsor: University of Mary Hardin-Baylor
• Collaborator: Dymatize Inc.
• Information provided by (Responsible Party): University of Mary Hardin-Baylor

Tracking Information

• First Submitted Date: September 11, 2018
• First Posted Date: September 19, 2018
• Last Update Posted Date: March 28, 2019
• Actual Study Start Date: July 23, 2018
• Actual Primary Completion Date: October 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2019)

• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Resting Energy Expenditure (REE) [ Time Frame: REE completed every hour for four hours post ingestion ]
  The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changing caloric expenditure via resting energy expenditure (REE) in daily, but modest caffeine consumers. This will be accomplished by observing caloric expenditure over a four hour time period post ingestion of the supplement as compared to baseline caloric expenditure pre-supplementation.
• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Heart Rate [ Time Frame: Heart rate taken every hour for four hours post ingestion ]
  The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changing heart rate as measured by Omron HEM-907XL professional blood pressure monitor in daily, but modest caffeine consumers. This will be accomplished by observing heart rate over a four hour time period post ingestion of the supplement as compared to baseline heart rate pre-supplementation.
• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Blood Pressure [ Time Frame: Blood pressure taken every hour for four hours post ingestion ]
  The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changes in both systolic and diastolic blood pressure as measured by Omron HEM-907XL professional blood pressure monitor in daily, but modest caffeine consumers. This will be accomplished by observing blood pressure over a four hour time period post ingestion of the supplement as compared to baseline blood pressure pre-supplementation.
• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Mood Responses [ Time Frame: VAS values recorded every hour for four hours post ingestion ]
  The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changes in mood as measured by the Visual Analog Scale (VAS) in daily, but modest caffeine consumers. This will be accomplished by observing changes in mood over a four hour time period post ingestion of the supplement as compared to their baseline mood response pre-supplementation. The VAS measures levels of energy, focus, concentration, alertness, and fatigue.The VAS is used to measure attitudes over a continuum ranging from "lowest possible" to "highest possible". Participants are required to mark a line along a 10 centimeter line with one end titled "lowest possible" and the opposite end titled "highest possible". Scores for the scale range from 0 to 10 with levels of energy, focus, concentration, and alertness being towards the higher end of the scale, closer to 10. Levels of fatigue should be towards the lower end of the scale, closer to 0.

Original Primary Outcome Measures (submitted: September 18, 2018)

• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Resting Energy Expenditure (REE) [ Time Frame: REE completed every hour for four hours post ingestion ]
  The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on increasing caloric expenditure via resting energy expenditure (REE) in daily, but modest caffeine consumers. This will be accomplished by observing caloric expenditure over a four hour time period post ingestion of the supplement as compared to baseline caloric expenditure pre-supplementation.
• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Heart Rate [ Time Frame: Heart rate taken every hour for four hours post ingestion ]
  The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on increasing heart rate as measured by Omron HEM-907XL professional blood pressure monitor in daily, but modest caffeine consumers. This will be accomplished by observing heart rate over a four hour time period post ingestion of the supplement as compared to baseline heart rate pre-supplementation.
• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Blood Pressure [ Time Frame: Blood pressure taken every hour for four hours post ingestion ]
  The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changes in both systolic and diastolic blood pressure as measured by Omron HEM-907XL professional blood pressure monitor in daily, but modest caffeine consumers. This will be accomplished by observing blood pressure over a four hour time period post ingestion of the supplement as compared to baseline blood pressure pre-supplementation.
• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Mood Responses [ Time Frame: VAS values recorded every hour for four hours post ingestion ]
  The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changes in mood as measured by the Visual Analog Scale (VAS) in daily, but modest caffeine consumers. This will be accomplished by observing changes in mood over a four hour time period post ingestion of the supplement as compared to their baseline mood response pre-supplementation. The VAS measures levels of energy, focus, concentration, alertness, and fatigue.The VAS is used to measure attitudes over a continuum ranging from "lowest possible" to "highest possible". Participants are required to mark a line along a 10 centimeter line with one end titled "lowest possible" and the opposite end titled "highest possible". Scores for the scale range from 0 to 10 with levels of energy, focus, concentration, and alertness being towards the higher end of the scale, closer to 10. Levels of fatigue should be towards the lower end of the scale, closer to 0.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Three groups: placebo, caffeine (plus Teacrine and Cayenne) and caffeine (plus Teacrine)

Masking: Double (Participant, Investigator)
Primary Purpose: Other

Condition

• Energy Metabolism
• Heart Rate
• Blood Pressure
• Mood

Intervention

• Drug: Sugar Pill (placebo)
  Taken orally in capsule form
• Dietary Supplement: Caffeine (plus Teacrine and Cayenne)
  Taken orally in capsule form
• Dietary Supplement: Caffeine (plus Teacrine)
  Taken orally in capsule form

Study Arms

• Placebo Comparator: Sugar Pill (Placebo)
  Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments.
  Intervention: Drug: Sugar Pill (placebo)
• Experimental: Caffeine (plus Teacrine and Cayenne)
  Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments.
  Intervention: Dietary Supplement: Caffeine (plus Teacrine and Cayenne)
• Experimental: Caffeine (plus Teacrine)
  Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments.
  Intervention: Dietary Supplement: Caffeine (plus Teacrine)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 18, 2018): 14
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 31, 2018
• Actual Primary Completion Date: October 31, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03678116
• Other Study ID Numbers: AMP-1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Mary Hardin-Baylor
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Mary Hardin-Baylor
• Original Study Sponsor: Same as current
• Collaborators: Dymatize Inc.

Investigators

• Principal Investigator: Lemuel W Taylor IV, PhD; UMHB Human Performance Lab

• PRS Account: University of Mary Hardin-Baylor
• Verification Date: March 2019