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

NCT ID: NCT04352998

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-16
• Study Completion Date: 2016-05-16

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

One dose pre-workout supplement condition

One dose/serving of a multi-ingredient pre-workout supplement was administered to the subjects.

Group Type: ACTIVE_COMPARATOR

One dose pre-workout condition

Intervention Type: DIETARY_SUPPLEMENT

one dose of a multi-ingredient pre-workout supplement

Two dose pre-workout supplement condition

Two doses/servings of a multi-ingredient pre-workout supplement was administered to the subjects.

Group Type: ACTIVE_COMPARATOR

Two dose pre-workout condition

Intervention Type: DIETARY_SUPPLEMENT

two doses of a multi-ingredient pre-workout supplement

Placebo condition

One dose/serving of a placebo was administered to the subjects.

Group Type: PLACEBO_COMPARATOR

Placebo condition

Intervention Type: DIETARY_SUPPLEMENT

one dose of a placebo

Interventions

One dose pre-workout condition

one dose of a multi-ingredient pre-workout supplement

Intervention Type: DIETARY_SUPPLEMENT

Two dose pre-workout condition

two doses of a multi-ingredient pre-workout supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo condition

one dose of a placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, La Crosse

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Nova Southeastern University

OTHER

Sponsor Role: collaborator

Northern Illinois University

OTHER

Sponsor Role: lead

Responsible Party

Clayton Camic

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clayton Camic, PHD

Role: PRINCIPAL_INVESTIGATOR

Northern Illinois University

Other Identifiers

NorthernIU

Identifier Type: -

Identifier Source: org_study_id