Effects of a Multi-Ingredient Pre-Workout Supplement on Energy Expenditure During Running

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study was to examine the acute effects of one versus two doses of a multi-ingredient pre-workout supplement on energy expenditure during moderate-intensity treadmill running. In addition, our second aim was to investigate the responses of associated metabolic factors (i.e. substrate utilization, measures of gas exchange), perceived exertion, and resting cardiovascular variables with one and two doses of the pre-workout supplement.

Detailed Description
-----------------
This study utilized a randomized, double-blind, placebo-controlled, within-subjects crossover design (Figure 1). Each subject was required to visit the laboratory on five occasions with 72-96 hours between sessions. During the first laboratory visit, each subject performed an incremental test on a treadmill to familiarize the subjects with the testing procedures. For the second laboratory visit, each subject performed an incremental treadmill test to exhaustion to determine their ventilatory threshold (VT). The third laboratory visit was completed in the morning (06:00-09:00) and required subjects to consume a standardized meal after fasting overnight (8 hours) and sat quietly for 30 minutes before baseline heart rate and blood pressure values were recorded. The subjects were then randomly assigned to ingest the supplement (one or two doses) or placebo and sit quietly for another 30 minutes. The ingredients of the supplement (Cellucor, Bryan, TX) are provided in Table 1. The placebo was non-energetic and controlled for similar appearance and taste. At the 15-minute and 30-minute post-ingestion periods (of the pre-workout supplement or placebo), resting heart rate and blood pressure were recorded for a second and third time, respectively. Subjects then performed a 30-minute constant-velocity treadmill run at 90% of their VT. The subjects then returned to the laboratory for their fourth and fifth visits to ingest the remaining substances (1-dose, 2-dose, or placebo) and undergo the same testing procedures (including time of day) as the third visit. Each subject recorded 2-day food logs (MyFitnessPal, Inc., USA) prior to each laboratory visit.

Official Title
-----------------
Effects of One Versus Two Doses of a Multi-Ingredient Pre-Workout Supplement on Metabolic Factors and Perceived Exertion During Moderate-Intensity Running in Females

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: One dose pre-workout condition
* Dietary Supplement: Two dose pre-workout condition
* Dietary Supplement: Placebo condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ran ≥ 16 km per week Exclusion Criteria: (i) history of medical or surgical events, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders; (ii) use of any medication; (iii) use of nutritional supplements; (iv) habitual use of caffeine (≥ one cup of coffee or caffeinated beverage per day); or (v) participation in another clinical trial or investigation of another investigational product within 30 days prior to screening/enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One dose pre-workout supplement condition<br>One dose/serving of a multi-ingredient pre-workout supplement was administered to the subjects. | Dietary Supplement: One dose pre-workout condition<br>* one dose of a multi-ingredient pre-workout supplement<br>|
| Active Comparator: Two dose pre-workout supplement condition<br>Two doses/servings of a multi-ingredient pre-workout supplement was administered to the subjects. | Dietary Supplement: Two dose pre-workout condition<br>* two doses of a multi-ingredient pre-workout supplement<br>|
| Placebo Comparator: Placebo condition<br>One dose/serving of a placebo was administered to the subjects. | Dietary Supplement: Placebo condition<br>* one dose of a placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure | energy expenditure measured as kcals per minute | 30 minutes of exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substrate utilization | fat and carbohydrate oxidation | 30 minutes of exercise | 
| measures of gas exchange | oxygen consumption, respiratory exchange ratio | 30 minutes of exercise | 
| perceived exertion | ratings of perceived exertion (RPE) | 30 minutes of exercise | 
| resting cardiovascular variables | heart rate, systolic and diastolic blood pressure | baseline and 30 minutes post-ingestion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caffeine, substrate utilization, thermogenic, fat oxidation