Effects of a Thermogenic Dietary Supplement on Metabolic, Hemodynamic, &

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03678116
Study type	Interventional
Source	University of Mary Hardin-Baylor
Contact
Status	Completed
Phase	N/A
Start date	July 23, 2018
Completion date	October 31, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms