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

NCT03678116 | Completed

• 1 other identifier: AMP-1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Energy Metabolism; Heart Rate; Blood Pressure; Mood

Keywords

caffeine; metabolism

Outcome Measures

Primary Outcomes (4)

• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Resting Energy Expenditure (REE)

  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.

  REE completed every hour for four hours post ingestion

• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Heart Rate

  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.

  Heart rate taken every hour for four hours post ingestion

• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Blood Pressure

  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.

  Blood pressure taken every hour for four hours post ingestion

• Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Mood Responses

  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.

  VAS values recorded every hour for four hours post ingestion

Study Arms (3)

Sugar Pill (Placebo)

PLACEBO COMPARATOR

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.

Drug: Sugar Pill (placebo)

Caffeine (plus Teacrine and Cayenne)

EXPERIMENTAL

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.

Dietary Supplement: Caffeine (plus Teacrine and Cayenne)

Caffeine (plus Teacrine)

EXPERIMENTAL

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.

Dietary Supplement: Caffeine (plus Teacrine)

Interventions

Sugar Pill (placebo) DRUG

Taken orally in capsule form

Sugar Pill (Placebo)

Caffeine (plus Teacrine and Cayenne) DIETARY_SUPPLEMENT

Taken orally in capsule form

Caffeine (plus Teacrine and Cayenne)

Caffeine (plus Teacrine) DIETARY_SUPPLEMENT

Taken orally in capsule form

Caffeine (plus Teacrine)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mary Hardin-Baylor: lead
• Dymatize Inc.: collaborator

Study Sites (1)

UMHB Human Performance Lab

Belton, Texas, 76513, United States

Location

MeSH Terms

Interventions

Sugars; Caffeine

Intervention Hierarchy (Ancestors)

Carbohydrates; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lemuel W Taylor IV, PhD

  UMHB Human Performance Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 19, 2018
• Study Start: July 23, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)