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

NCT ID: NCT03678116

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2018-10-31

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.

Conditions

Energy Metabolism; Heart Rate; Blood Pressure; Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Sugar Pill (placebo)

Intervention Type: DRUG

Taken orally in capsule form

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.

Group Type: EXPERIMENTAL

Caffeine (plus Teacrine and Cayenne)

Intervention Type: DIETARY_SUPPLEMENT

Taken orally in capsule form

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.

Group Type: EXPERIMENTAL

Caffeine (plus Teacrine)

Intervention Type: DIETARY_SUPPLEMENT

Taken orally in capsule form

Interventions

Sugar Pill (placebo)

Taken orally in capsule form

Intervention Type: DRUG

Caffeine (plus Teacrine and Cayenne)

Taken orally in capsule form

Intervention Type: DIETARY_SUPPLEMENT

Caffeine (plus Teacrine)

Taken orally in capsule form

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dymatize Inc.

UNKNOWN

Sponsor Role: collaborator

University of Mary Hardin-Baylor

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lemuel W Taylor IV, PhD

Role: PRINCIPAL_INVESTIGATOR

UMHB Human Performance Lab

Locations

UMHB Human Performance Lab

Belton, Texas, United States

Countries

United States

Other Identifiers

AMP-1

Identifier Type: -

Identifier Source: org_study_id