Clinical trial NCT02952014: Assessment of a Pre-Workout Dietary Supplement
Official title: Pharmacokinetic, Thermogenic, Hemodynamic, Ergogenic Assessment of a Pre-Workout Dietary Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Nutrabolt
First posted: 2016-11-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the acute effects of a pre-workout dietary supplement on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.

Detailed description: A number of nutritional strategies have been developed to optimize nutrient delivery prior to exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to, during and/or following exercise. As a result a number of pre-workout supplements have been developed to increase energy availability, promote vasodilation and/or positively affect exercise capacity. The purpose of this study is to investigate the potential ergogenic value of acute ingestion of a pre-workout dietary supplement prior to exercise.

Eligibility criteria: Inclusion Criteria:

* you are an apparently healthy and recreationally active man or woman between the ages of 18 and 40;
* you will need to have at least six months immediate prior history of resistance training on the bench press and leg press or squat;

Exclusion Criteria:

* you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypo-tension, thyroid disease, arrhythmia and/or cardiovascular disease;
* you are currently using prescription medications;
* you have an intolerance to caffeine and/or other natural stimulants;
* you are pregnant or a lactating female or plan to become pregnant with the next month;
* you have a history of smoking;
* you drink excessively (i.e., 12 drinks per week or more);

Primary outcomes:
measure: Optimize nutrient delivery prior to exercise by assessing; cognitive function (i.e., Stroop Color and Word Test and Word Recall Test).
timeFrame: Three weeks
measure: Optimize nutrient delivery prior to exercise by assessing Readiness to Perform Visual Analog Scale.
timeFrame: Three weeks
measure: Optimize nutrient delivery prior to exercise by assessing Resting Energy Expenditure.
timeFrame: Three weeks
measure: Optimize nutrient delivery prior to exercise by assessing Heart Rate.
timeFrame: Three weeks
measure: Optimize nutrient delivery prior to exercise by assessing Blood Pressure.
timeFrame: Three weeks
measure: Optimize nutrient delivery prior to exercise by assessing ECG.
timeFrame: Three weeks
Secondary outcomes:
measure: Measure standard clinical chemistry panels in the blood to evaluate safety.
timeFrame: Three weeks
measure: Measure Heart Rate to evaluate safety.
timeFrame: Three weeks
measure: Measure Blood Pressure to evaluate safety.
timeFrame: Three weeks
measure: Measure ECG to evaluate safety.
timeFrame: Three weeks
Other outcomes:
Locations:
city: College Station
country: United States
facility: Exercise & Sport Nutrition Laboratory
state: Texas
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung YP, Earnest CP, Koozehchian M, Galvan E, Dalton R, Walker D, Rasmussen C, Murano PS, Greenwood M, Kreider RB. Effects of acute ingestion of a pre-workout dietary supplement with and without p-synephrine on resting energy expenditure, cognitive function and exercise performance. J Int Soc Sports Nutr. 2017 Jan 12;14:3. doi: 10.1186/s12970-016-0159-2. eCollection 2017.