NCT04352998

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

April 16, 2020

Last Update Submit

April 16, 2020

Conditions

Keywords

caffeinesubstrate utilizationthermogenicfat oxidation

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure

    energy expenditure measured as kcals per minute

    30 minutes of exercise

Secondary Outcomes (4)

  • substrate utilization

    30 minutes of exercise

  • measures of gas exchange

    30 minutes of exercise

  • perceived exertion

    30 minutes of exercise

  • resting cardiovascular variables

    baseline and 30 minutes post-ingestion

Study Arms (3)

One dose pre-workout supplement condition

ACTIVE COMPARATOR

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

Dietary Supplement: One dose pre-workout condition

Two dose pre-workout supplement condition

ACTIVE COMPARATOR

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

Dietary Supplement: Two dose pre-workout condition

Placebo condition

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo condition

Interventions

one dose of a multi-ingredient pre-workout supplement

One dose pre-workout supplement condition

two doses of a multi-ingredient pre-workout supplement

Two dose pre-workout supplement condition
Placebo conditionDIETARY_SUPPLEMENT

one dose of a placebo

Placebo condition

Eligibility Criteria

Age19 Years - 29 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ran ≥ 16 km per week

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Clayton Camic, PHD

    Northern Illinois University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 20, 2020

Study Start

May 16, 2016

Primary Completion

May 16, 2016

Study Completion

May 16, 2016

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share