Clinical trial NCT04539054: Pre-workout Supplement Versus Caffeine on Energy Expenditure.
Official title: Effects of a Multi-ingredient Pre-workout Supplement Versus Caffeine on Energy Expenditure and Feelings of Fatigue During Low-intensity Treadmill Exercise in College-aged Males.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: supplementation
ergogenic aid
metabolic rate
energy
substrate utilization
Lead sponsor: Northern Illinois University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study was to examine the acute effects of a multi-ingredient pre-workout supplement versus an ergogenic dose of caffeine (6 mg/kg) on energy expenditure during low-intensity exercise. The effects of these substances on substrate utilization, gas exchange, and psychological factors were also investigated. Twelve males (mean ± SD: age = 22.8 ± 2.4 years) completed three bouts of 60-min of treadmill exercise at 4.8-6.4 km/hr on separate days after consuming a pre-workout supplement, 6 mg/kg of caffeine, or placebo in a randomized fashion. The pre-workout and caffeine supplements resulted in significantly greater energy expenditure (p \< 0.001, p = 0.006, respectively), VO2 (p \< 0.001, p = 0.007, respectively), VCO2 (p = 0.006, p = 0.049, respectively), and VE (p \< 0.001, p = 0.007, respectively), but not rates of fat or carbohydrate oxidation or respiratory exchange ratio compared to placebo (collapsed across condition). In addition, the pre-workout supplement increased feelings of alertness (p = 0.015) and focus (p = 0.005) 30-minutes post-ingestion and decreased feelings of fatigue (p = 0.014) during exercise compared to placebo (collapsed across condition). Thus, the pre-workout supplement increased energy expenditure and measures of gas exchange to the same extent as 6 mg/kg of caffeine with concomitant increased feelings of alertness and focus and decreased feelings of fatigue.


Eligibility criteria: Inclusion Criteria:

* Male

Exclusion Criteria:

* history of medical or surgical events, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders;
* use of any medications
* use of nutritional supplements
* habitual use of caffeine (≥1 caffeinated beverage per day)
* participation in another clinical trial or investigation of another investigational product within 30 days prior to screening/enrollment.

Primary outcomes:
measure: Energy expenditure
timeFrame: Measured continuously during 60 minutes of exercise for all three supplement conditions
Secondary outcomes:
measure: Oxygen consumption
timeFrame: Measured continuously during 60 minutes of exercise for all three supplement conditions
measure: Carbon dioxide production
timeFrame: Measured continuously during 60 minutes of exercise for all three supplement conditions
measure: Minute ventilation
timeFrame: Measured continuously during 60 minutes of exercise for all three supplement conditions
measure: Feelings of fatigue
timeFrame: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
measure: Feelings of energy
timeFrame: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
measure: Feelings of focus
timeFrame: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
measure: Feelings of alertness
timeFrame: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
measure: Rate of fat oxidation
timeFrame: Measured continuously during 60 minutes of exercise for all three supplement conditions
measure: Rate of carbohydrate oxidation
timeFrame: Measured continuously during 60 minutes of exercise for all three supplement conditions
Other outcomes:
Locations:
city: DeKalb
country: United States
facility: Exercise Physiology Laboratory
state: Illinois
Study officials:
affiliation: Northern Illinois University
name: Clayton L Camic, PhD
role: PRINCIPAL_INVESTIGATOR
References: