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Completed

NCT Number: NCT04352998

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

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.

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Key information

Conditions

Age range

19 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

One dose pre-workout condition

Dietary Supplement

one dose of a multi-ingredient pre-workout supplement

Two dose pre-workout condition

Dietary Supplement

two doses of a multi-ingredient pre-workout supplement

Placebo condition

Dietary Supplement

one dose of a placebo

Primary outcomes

  1. Energy expenditure

    Time frame: 30 minutes of exercise

    energy expenditure measured as kcals per minute

Secondary outcomes

  1. substrate utilization

    Time frame: 30 minutes of exercise

    fat and carbohydrate oxidation

  2. measures of gas exchange

    Time frame: 30 minutes of exercise

    oxygen consumption, respiratory exchange ratio

  3. perceived exertion

    Time frame: 30 minutes of exercise

    ratings of perceived exertion (RPE)

  4. resting cardiovascular variables

    Time frame: baseline and 30 minutes post-ingestion

    heart rate, systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Northern Illinois University

Other

Collaborators

  • Mayo Clinic
  • Nova Southeastern University
  • University of Wisconsin, La Crosse

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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